FDA 510(k)

沃特克单环输尿管支架

K号: K201436 · 2021-02-25

决定日期2021-02-25

产品代码FAD

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决定实质等同

器械摘要

Vortek Single Loop Ureteral Stent is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast Corp.. It received FDA 510(k) clearance on 2021-02-25 under 510(k) number K201436. The device is classified under product code FAD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Vortek Single Loop Ureteral Stent?

Vortek Single Loop Ureteral Stent is a medical device that received FDA 510(k) clearance on 2021-02-25. The listed applicant is Coloplast Corp.. The 510(k) number is K201436.

When did Vortek Single Loop Ureteral Stent receive FDA 510(k) clearance?

Vortek Single Loop Ureteral Stent received FDA 510(k) clearance on 2021-02-25, under 510(k) number K201436.

Who is the listed applicant for Vortek Single Loop Ureteral Stent?

The FDA 510(k) record lists Coloplast Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vortek Single Loop Ureteral Stent?

The FDA product code for Vortek Single Loop Ureteral Stent is FAD.

列明Coloplast Corp.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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相关器械（代码：FAD）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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