FDA 510(k)

TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool

K-번호: K190884 · 2019-12-26

결정일2019-12-26

제품 코드GDW

자문 위원회SU [원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.]

결정대체적으로 동일

기기 요약

TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool is the device name listed in this FDA 510(k) record. The listed applicant is Datascope Corp.. It received FDA 510(k) clearance on 2019-12-26 under 510(k) number K190884. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool?

TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool is a medical device that received FDA 510(k) clearance on 2019-12-26. The listed applicant is Datascope Corp.. The 510(k) number is K190884.

When did TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool receive FDA 510(k) clearance?

TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool received FDA 510(k) clearance on 2019-12-26, under 510(k) number K190884.

Who is the listed applicant for TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool?

The FDA 510(k) record lists Datascope Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool?

The FDA product code for TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool is GDW.

Datascope Corp.를 신청인으로 등재한 기타 기록

K181122카디오세이브 인트라-아오르틱 밸loon 펌프 K172305CS100/CS100i 내대동맥 balloon 펌프, CS300 내대동맥 balloon 펌프 K163542카디오세이브 하이브리드 및 레스큐 이나오아르토타임 팩스, 카디오세이브 리온 배터리 이동 및 보관 케이스

관련 기기 (코드: GDW)

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