FDA 510(k)

Dornier Ureteral Stent

K号: K190312 · 2019-11-15

决定日期2019-11-15

产品代码FAD

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决定实质等同

器械摘要

Dornier Ureteral Stent is the device name listed in this FDA 510(k) record. The listed applicant is Dornier Medtech America, Inc.. It received FDA 510(k) clearance on 2019-11-15 under 510(k) number K190312. 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 Dornier Ureteral Stent?

Dornier Ureteral Stent is a medical device that received FDA 510(k) clearance on 2019-11-15. The listed applicant is Dornier Medtech America, Inc.. The 510(k) number is K190312.

When did Dornier Ureteral Stent receive FDA 510(k) clearance?

Dornier Ureteral Stent received FDA 510(k) clearance on 2019-11-15, under 510(k) number K190312.

Who is the listed applicant for Dornier Ureteral Stent?

The FDA 510(k) record lists Dornier Medtech America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dornier Ureteral Stent?

The FDA product code for Dornier Ureteral Stent is FAD.

列明Dornier Medtech America, Inc.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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