FDA 510(k)

通过气管支架系统

K号: K220424 · 2022-07-08

决定日期2022-07-08

产品代码JCT

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决定实质等同

器械摘要

Through the Scope 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 2022-07-08 under 510(k) number K220424. 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 Through the Scope Tracheal Stent System?

Through the Scope Tracheal Stent System is a medical device that received FDA 510(k) clearance on 2022-07-08. The listed applicant is Micro-Tech (Nanjing) Co., Ltd.. The 510(k) number is K220424.

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

Through the Scope Tracheal Stent System received FDA 510(k) clearance on 2022-07-08, under 510(k) number K220424.

Who is the listed applicant for Through the Scope 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 Through the Scope Tracheal Stent System?

The FDA product code for Through the Scope 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。

K252492可视化接入与输送导管；PB数字控制器 K251692高级组织切除设备 K250229双重作用组织闭合装置 K243388一次性远端帽 K243471提取篮 K230127胆道塑料支架，胆道塑料支架导引器，胆道塑料支架套装，胆道塑料支架导引器/短导丝兼容型，胆道塑料支架套装/短导丝兼容型

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官方来源

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