FDA 510(k)

Tracheal Stent System

Número K: K202204 · 2021-09-01

RequerenteMicro-Tech (Nanjing) Co., Ltd.

Data da decisão2021-09-01

Código do produtoJCT

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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Dispositivos Relacionados (Código: JCT)

K230269Ultraflex™ Tracheobronchial Stent SystemBoston Scientific Corporation K220424Through the Scope Tracheal Stent SystemMicro-Tech (Nanjing) Co., Ltd.K212403Tracheal Stent System (Y-Shaped)Micro-Tech (Nanjing) Co., Ltd.K201342HANAROSTENT Trachea/Bronchium (CCC)M.I.Tech Co., Ltd.K181200Sistema de Stent Tracheobronquial AEROminiMerit Medical Systems, Inc.K152842WALLSTENT RP ENDOPROSTHESIS TRACHEOBRONCHIAL, WALLSTENT ENDOPROSTHESIS TRACHEOBRONCHIALBoston Scientific Corporation

Fonte oficial

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