FDA 510(k)

气管支架系统（Y型）

K号: K212403 · 2021-10-30

决定日期2021-10-30

产品代码JCT

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决定实质等同

器械摘要

Tracheal Stent System (Y-Shaped) 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 2021-10-30 under 510(k) number K212403. 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 (Y-Shaped)?

Tracheal Stent System (Y-Shaped) is a medical device that received FDA 510(k) clearance on 2021-10-30. The listed applicant is Micro-Tech (Nanjing) Co., Ltd.. The 510(k) number is K212403.

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

Tracheal Stent System (Y-Shaped) received FDA 510(k) clearance on 2021-10-30, under 510(k) number K212403.

Who is the listed applicant for Tracheal Stent System (Y-Shaped)?

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 (Y-Shaped)?

The FDA product code for Tracheal Stent System (Y-Shaped) 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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