{"id":3019,"date":"2024-10-17T22:15:28","date_gmt":"2024-10-17T22:15:28","guid":{"rendered":"https:\/\/veraqueconsulting.com\/co\/?p=3019"},"modified":"2025-06-30T19:42:31","modified_gmt":"2025-06-30T19:42:31","slug":"classification-and-grouping-for-stents-in-colombia","status":"publish","type":"post","link":"https:\/\/veraqueconsulting.com\/co\/classification-and-grouping-for-stents-in-colombia\/","title":{"rendered":"Classification and Grouping for Stents in Colombia"},"content":{"rendered":"

A stent is a small mesh tube that is placed inside a hollow structure in the body to keep it open. As mentioned in our <\/span>Classification and Grouping Guide<\/span><\/a>, there are a series of rules to consider when classifying and grouping medical devices in <\/span>Colombia<\/span><\/b>.\u00a0\u00a0<\/span>\u00a0<\/span><\/p>\n

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In this article we will focus on explaining strategies to classify and group a stent following simple general rules. We also detail some particularities that can be found according to our everyday experience.<\/span>\u00a0<\/span><\/p>\n

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General characteristics of a Stent<\/span><\/b>\u00a0<\/span><\/h3>\n

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Stents can be sold mounted in <\/span>balloon catheters or alone. The <\/span>common practice is to find them in the mounted presentation. The <\/span>material <\/span>is generally of medical grade stainless steel or a cobalt alloy metal. These can even include a drug with the purpose of avoiding stenosis. Nevertheless, they are sold in sterilized tyvek pouches and in different sizes, by means of the catheter length and stent diameters (gauged in Frenchs).<\/span>\u00a0<\/span><\/p>\n

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On the other hand, manufacturers tend to sell stents with different commercial names. This is related to alternative technologies or intended uses.<\/span>\u00a0<\/span><\/p>\n

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Finally, it is worth mentioning that the stent is used in a catheterization procedure and there are a set of supplies related to the process (e.g. pressure transducers, guide catheters, introducers, etc.). These products are not sold under the same commercial name of the stent or included in the same package.<\/span>\u00a0<\/span><\/p>\n

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Every point described so far has regulatory implications that we will explain in the following section.<\/span>\u00a0<\/span><\/p>\n

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Classification according to the level of risk<\/span><\/b>\u00a0<\/span><\/h3>\n

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Stents by their nature are classified as implantable medical devices and <\/span>considered <\/span>Class IIb <\/span><\/b>due to their level of risk. <\/span>However, if stents are employed in direct contact with the heart, central circulatory system, or central nervous system, they are classified as <\/span>Class III<\/span><\/b>, reflecting their higher risk profile.<\/span>\u00a0<\/span><\/p>\n

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Grouping for Sanitary Registration purposes<\/span><\/b>\u00a0<\/span><\/h3>\n

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The classification for a Stent is pretty straightforward. Yet, it is still necessary to consider a few points regarding the grouping criteria. Specifically, stents can be grouped in the same Sanitary registration if they:<\/span>\u00a0<\/span><\/p>\n

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