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FDA 510(k)

Tracheal Stent System

K-Number: K202204 · 2021-09-01

ApplicantMicro-Tech (Nanjing) Co., Ltd.
Decision Date2021-09-01
Product CodeJCT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

What is the Tracheal Stent System?

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

When was Tracheal Stent System approved by the FDA?

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

What company makes Tracheal Stent System?

Tracheal Stent System is manufactured by Micro-Tech (Nanjing) Co., Ltd..

What is the FDA product code for Tracheal Stent System?

The FDA product code for Tracheal Stent System is JCT.

Related Clinical Trials

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Related Devices (Code: JCT)

K152842WALLSTENT RP ENDOPROSTHESIS TRACHEOBRONCHIAL, WALLSTENT ENDOPROSTHESIS TRACHEOBRONCHIALBoston Scientific Corporation K181200AEROmini Tracheobronchial Stent SystemMerit Medical Systems, Inc. K201342HANAROSTENT Trachea/Bronchium (CCC)M.I.Tech Co., Ltd. K212403Tracheal Stent System (Y-Shaped)Micro-Tech (Nanjing) Co., Ltd. K220424Through the Scope Tracheal Stent SystemMicro-Tech (Nanjing) Co., Ltd. K230269Ultraflex™ Tracheobronchial Stent SystemBoston Scientific Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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