FDA 510(k)

Tiche PTA Balloon Dilatation Catheter

K-번호: K212215 · 2022-07-19

결정일2022-07-19

제품 코드LIT

자문 위원회CV

결정Substantially Equivalent

기기 요약

Tiche PTA Balloon Dilatation Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Brosmed Medical Co., Ltd.. It received FDA 510(k) clearance on 2022-07-19 under 510(k) number K212215. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Tiche PTA Balloon Dilatation Catheter?

Tiche PTA Balloon Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2022-07-19. The listed applicant is Brosmed Medical Co., Ltd.. The 510(k) number is K212215.

When did Tiche PTA Balloon Dilatation Catheter receive FDA 510(k) clearance?

Tiche PTA Balloon Dilatation Catheter received FDA 510(k) clearance on 2022-07-19, under 510(k) number K212215.

Who is the listed applicant for Tiche PTA Balloon Dilatation Catheter?

The FDA 510(k) record lists Brosmed Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tiche PTA Balloon Dilatation Catheter?

The FDA product code for Tiche PTA Balloon Dilatation Catheter is LIT.

Brosmed Medical Co., Ltd.를 신청인으로 등재한 기타 기록

K243704Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation Catheter K241478Tri-Wedge PTA Scoring Balloon Dilatation Catheter K230705POT PTCA Balloon Dilatation Catheter K203390Artimes pro balloon 확장 카테터 K160941Castor, Achilles and Hermes NC PTA Balloon Dilatation Catheter K153742아폴로 balloon 확장 캐터터

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