FDA 510(k)

气管支架系统

K号: K202204 · 2021-09-01

决定日期2021-09-01

产品代码JCT

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决定实质等同

器械摘要

Tracheal Stent System is the device name listed in this FDA 510(k) record. The listed applicant is Micro-Tech (Nanjing) Co., Ltd.. It received FDA 510(k) clearance on 2021-09-01 under 510(k) number K202204. The device is classified under product code JCT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Tracheal Stent System?

Tracheal Stent System is a medical device that received FDA 510(k) clearance on 2021-09-01. The listed applicant is Micro-Tech (Nanjing) Co., Ltd.. The 510(k) number is K202204.

When did Tracheal Stent System receive FDA 510(k) clearance?

Tracheal Stent System received FDA 510(k) clearance on 2021-09-01, under 510(k) number K202204.

Who is the listed applicant for Tracheal Stent System?

The FDA 510(k) record lists Micro-Tech (Nanjing) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tracheal Stent System?

The FDA product code for Tracheal Stent System is JCT.

列明Micro-Tech (Nanjing) Co., Ltd.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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