FDA 510(k)

Through the Scope Tracheal Stent System

K-번호: K220424 · 2022-07-08

결정일2022-07-08

제품 코드JCT

자문 위원회SU

결정Substantially Equivalent

기기 요약

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.

자주 묻는 질문

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.

Micro-Tech (Nanjing) Co., Ltd.를 신청인으로 등재한 기타 기록

K252492Visualized Access and Delivery Catheter; PB Digital Controller K251692고급 조직 절제 장비 K250229Dual Action Tissue Closure Device K243388Disposable Distal Cap K243471Extraction Basket K230127bile 채널 플라스틱 스탠트, bile 채널 플라스틱 스탠트 인트로듀서, bile 채널 플라스틱 스탠트 세트, bile 채널 플라스틱 스탠트 인트로듀서/단쇠와 호환 가능, bile 채널 플라스틱 스탠트 세트/단쇠와 호환 가능

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