FDA 510(k)

沃特克输尿管双环支架

K号: K180057 · 2018-03-09

决定日期2018-03-09

产品代码FAD

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决定实质等同

器械摘要

VORTEK URETERAL DOUBLE LOOP 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 2018-03-09 under 510(k) number K180057. 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 URETERAL DOUBLE LOOP STENT?

VORTEK URETERAL DOUBLE LOOP STENT is a medical device that received FDA 510(k) clearance on 2018-03-09. The listed applicant is Coloplast Corp.. The 510(k) number is K180057.

When did VORTEK URETERAL DOUBLE LOOP STENT receive FDA 510(k) clearance?

VORTEK URETERAL DOUBLE LOOP STENT received FDA 510(k) clearance on 2018-03-09, under 510(k) number K180057.

Who is the listed applicant for VORTEK URETERAL DOUBLE LOOP 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 URETERAL DOUBLE LOOP STENT?

The FDA product code for VORTEK URETERAL DOUBLE LOOP 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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