FDA 510(k)

Through the Scope Tracheal Stent System

Número K: K220424 · 2022-07-08

RequerenteMicro-Tech (Nanjing) Co., Ltd.

Data da decisão2022-07-08

Código do produtoJCT

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Outros registros que listam Micro-Tech (Nanjing) Co., Ltd. como candidato(a)

K252492Visualized Access and Delivery Catheter; PB Digital Controller K251692Dispositivo de Resseção de Tecido Avançado K250229Dual Action Tissue Closure Device K243388Disposable Distal Cap K243471Extraction Basket K230127Biliary Plastic Stent, Biliary Plastic Stent Introducer, Biliary Plastic Stent Set, Biliary Plastic Stent Introducer/ short-wire compatible, Biliary Plastic Stent Set/ short-wire compatible

Ver todos os 37 dispositivos →

Dispositivos Relacionados (Código: JCT)

K230269Ultraflex™ Tracheobronchial Stent SystemBoston Scientific Corporation K212403Tracheal 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.K181200Sistema de Stent Tracheobronquial AEROminiMerit Medical Systems, Inc.K152842WALLSTENT RP ENDOPROSTHESIS TRACHEOBRONCHIAL, WALLSTENT ENDOPROSTHESIS TRACHEOBRONCHIALBoston Scientific Corporation

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.