{"id":3061,"date":"2025-01-07T20:32:56","date_gmt":"2025-01-07T20:32:56","guid":{"rendered":"https:\/\/veraqueconsulting.com\/cr\/?p=3061"},"modified":"2025-06-30T19:54:04","modified_gmt":"2025-06-30T19:54:04","slug":"classification-and-grouping-of-balloon-catheters-in-costa-rica","status":"publish","type":"post","link":"https:\/\/veraqueconsulting.com\/cr\/classification-and-grouping-of-balloon-catheters-in-costa-rica\/","title":{"rendered":"Classification and Grouping of Balloon Catheters in Costa Rica"},"content":{"rendered":"<p><span data-contrast=\"none\">Balloon Catheters also known as dilatation catheters, stand as precise instruments in the array of medical devices. Employed to alleviate obstructions and stenosis across various bodily systems, they are a great exemplification of controlled intervention.\u00a0\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"none\">\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"none\">In this article, we will discuss their structure, diverse applications, and existing types of Balloon Catheters. Additionally, we will review general guidelines on their classification and grouping within the\u00a0<\/span><a href=\"https:\/\/veraqueconsulting.com\/cr\/guides\/ultimate-guide-for-regulatory-affairs-in-costa-rica\/\" target=\"_blank\" rel=\"noopener\"><b><span data-contrast=\"none\">Costa Rican regulatory framework<\/span><\/b><\/a><span data-contrast=\"none\">.\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"none\">\u00a0\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"none\">Structure and Uses of Balloon Catheters\u00a0<\/span><\/b><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;134245418&quot;:true,&quot;134245529&quot;:true,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:120,&quot;335559739&quot;:240}\">\u00a0<\/span><\/h3>\n<p>&nbsp;<\/p>\n<p><span data-contrast=\"none\">Balloon catheters are medical devices used in interventional procedures to treat obstructions or stenosis in different body systems. These types of catheters use their incorporated balloon to perform precise dilations in specific anatomical structures by controlled application of pressure through balloon inflation.\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"none\">\u00a0\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"none\">The basic design of a balloon catheter consists in a thin, flexible tube (usually made as polyethylene, polyurethane or silicone) with an inflatable balloon at one end, that can be inflated with fluid through an external inflation system connected to the device. Some models of balloon catheters add medication as part of the device, by coating the balloon with a drug to promote different results, like limiting the amount of restenosis, or prohibiting cell division.\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"none\">\u00a0\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"none\"><span class=\"TextRun SCXW213453107 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW213453107 BCX0\">Balloon Catheters are more commonly used in <\/span><span class=\"NormalTextRun SCXW213453107 BCX0\">percutaneous transluminal angioplasties <\/span><\/span><a class=\"Hyperlink SCXW213453107 BCX0\" href=\"https:\/\/www.yalemedicine.org\/clinical-keywords\/percutaneous-transluminal-angioplasty\" target=\"_blank\" rel=\"noreferrer noopener\"><span class=\"TextRun Underlined SCXW213453107 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"><span class=\"NormalTextRun SCXW213453107 BCX0\" data-ccp-charstyle=\"Hyperlink\">(PTA<\/span><span class=\"NormalTextRun SCXW213453107 BCX0\" data-ccp-charstyle=\"Hyperlink\">)<\/span><\/span><\/a><span class=\"TextRun SCXW213453107 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"none\"> <span class=\"NormalTextRun SCXW213453107 BCX0\">,<\/span><span class=\"NormalTextRun SCXW213453107 BCX0\"> but they can also be used for such procedures as tuboplasties and <\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW213453107 BCX0\">p<\/span><span class=\"NormalTextRun SpellingErrorV2Themed SCXW213453107 BCX0\">yeloplasties<\/span><span class=\"NormalTextRun SCXW213453107 BCX0\">.<\/span> <\/span>The common procedure for its use is to introduce the catheter into the targeted narrow vessel, and then inflate the balloon to a fixed size. The balloon then forces the blood vessel to expand, extending the lumen of the vessel, and improving blood flow. A stent may be inserted after this procedure, to ensure that the treated vessel remains opened, and the balloon is then deflated and withdrawn. <\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"none\">\u00a0\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"none\">Types of Balloon Catheters\u00a0<\/span><\/b><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;134245418&quot;:true,&quot;134245529&quot;:true,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:120,&quot;335559739&quot;:240}\">\u00a0<\/span><\/h3>\n<p><span data-contrast=\"none\">\u00a0\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"none\">There are several types of balloon catheters. The two most commonly used are:\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"none\">\u00a0\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"13\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"none\">Rapid Exchange (Rx): The rapid exchange catheter is currently the most widely used type of balloon catheter. They have a short construction and are designed for rapid exchange during a procedure.\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:0}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"13\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"2\" data-aria-level=\"1\"><span data-contrast=\"none\">Over the Wire (OTW): The OTW catheters are characterized by having a length that extends beyond the balloon\u2019s end. These catheters are designed to be inserted over a guidewire pre-placed in a vessel, and it follows the guide to the treatment site.\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:0}\">\u00a0<\/span><\/li>\n<\/ul>\n<p><span data-contrast=\"none\">\u00a0\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<h3><b><span data-contrast=\"none\">Classification and Grouping in Costa Rica <\/span><\/b><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;134245418&quot;:true,&quot;134245529&quot;:true,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:120,&quot;335559739&quot;:240}\">\u00a0<\/span><\/h3>\n<p><span data-contrast=\"none\">\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"none\">Depending on their intended use or the overall risk of the procedure, balloon catheters can have different classification groups. \u00a0Most balloon catheters dealing with heart or great vessels, or associated with a high-risk procedure, fall under\u00a0<\/span><b><span data-contrast=\"none\">Class 4<\/span><\/b><span data-contrast=\"none\"> medical devices<\/span><span data-contrast=\"none\">. However, those used for peripheral vessels fall under\u00a0<\/span><b><span data-contrast=\"none\">Class 2.<\/span><\/b><span data-contrast=\"none\">\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"none\">\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"none\">On the other hand, as analyzed in our\u00a0<\/span><a href=\"https:\/\/veraqueconsulting.com\/cr\/guides\/classification-and-grouping-ultimate-guide\/\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">Device Classification and Device Grouping Guide<\/span><\/a><span data-contrast=\"none\">, different variants of the same device can be included in the same sanitary registration, if they satisfy the following criteria:\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"none\">\u00a0\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"14\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"1\" data-aria-level=\"1\"><span data-contrast=\"none\">Same intended use.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:0}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"14\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"2\" data-aria-level=\"1\"><span data-contrast=\"none\">Same manufacturer.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:0}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"14\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"none\">More than one presentation can be included in the same registration, in which case all the presentations must be indicated in the application.<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:0}\">\u00a0<\/span><\/li>\n<\/ul>\n<ul>\n<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"14\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559683&quot;:0,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;hybridMultilevel&quot;}\" data-aria-posinset=\"4\" data-aria-level=\"1\"><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">Different sizes.<\/span><\/li>\n<\/ul>\n<p><span data-contrast=\"none\">\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"none\">It is important to note that, if there are variants of the same device that have an added medication,\u00a0<\/span><b><span data-contrast=\"none\">the medication variants will have to go on a different sanitary registration<\/span><\/b><span data-contrast=\"none\">\u00a0than their non-medication counterparts.\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><span data-contrast=\"none\">\u00a0\u00a0<\/span><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n<p><span data-contrast=\"none\">If you have any inquiries about the registration of balloon catheters or any other medical devices in the Costa Rican market, please feel free to contact us at\u00a0<\/span><a href=\"mailto:contact@veraqueconsulting.com\"><span data-contrast=\"none\">contact@veraqueconsulting.com<\/span><\/a><span data-contrast=\"none\">, or check our\u00a0<\/span><a href=\"https:\/\/veraqueconsulting.com\/cr\/guides\/\" target=\"_blank\" rel=\"noopener\"><span data-contrast=\"none\">guidelines.<\/span><\/a><span data-ccp-props=\"{&quot;134233117&quot;:false,&quot;134233118&quot;:false,&quot;335551550&quot;:1,&quot;335551620&quot;:1,&quot;335557856&quot;:16777215,&quot;335559738&quot;:0,&quot;335559739&quot;:216}\">\u00a0<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Balloon Catheters also known as dilatation catheters, stand as precise instruments in the array of medical devices. Employed to alleviate obstructions and stenosis across various bodily systems, they are a great exemplification of controlled intervention.\u00a0\u00a0\u00a0 \u00a0\u00a0 In this article, we will discuss their structure, diverse applications, and existing types of Balloon Catheters. Additionally, we will [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":3062,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[367,386],"tags":[],"class_list":["post-3061","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-classification","category-costa-rica"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.0 (Yoast SEO v28.0) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Classification and Grouping of Balloon Catheters in Costa Rica - Veraque Costa Rica<\/title>\n<meta name=\"description\" content=\"In this article, we analyze the classification of balloon catheters in Costa Rica. 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