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FDA 510(k)

Through the Scope Tracheal Stent System

K-Number: K220424 · 2022-07-08

ApplicantMicro-Tech (Nanjing) Co., Ltd.
Decision Date2022-07-08
Product CodeJCT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Other records listing Micro-Tech (Nanjing) Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252492Visualized Access and Delivery Catheter; PB Digital ControllerK251692Advanced Tissue Resection DeviceK250229Dual Action Tissue Closure DeviceK243388Disposable Distal CapK243471Extraction BasketK230127Biliary Plastic Stent, Biliary Plastic Stent Introducer, Biliary Plastic Stent Set, Biliary Plastic Stent Introducer/ short-wire compatible, Biliary Plastic Stent Set/ short-wire compatible

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Related Devices (Code: JCT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K230269Ultraflex™ Tracheobronchial Stent SystemBoston Scientific CorporationK212403Tracheal Stent System (Y-Shaped)Micro-Tech (Nanjing) Co., Ltd.K202204Tracheal Stent SystemMicro-Tech (Nanjing) Co., Ltd.K201342HANAROSTENT Trachea/Bronchium (CCC)M.I.Tech Co., Ltd.K181200AEROmini Tracheobronchial Stent SystemMerit Medical Systems, Inc.K152842WALLSTENT RP ENDOPROSTHESIS TRACHEOBRONCHIAL, WALLSTENT ENDOPROSTHESIS TRACHEOBRONCHIALBoston 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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