FDA 510(k)

Pacific Plus PTA Catheter

K-번호: K202800 · 2020-11-18

신청자Medtronic Vascular,Inc(Formerly D.B.A Ev3 Inc.,Covidien, LLC)

결정일2020-11-18

제품 코드LIT

자문 위원회CV

결정Substantially Equivalent

기기 요약

Pacific Plus PTA Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular,Inc(Formerly D.B.A Ev3 Inc.,Covidien, LLC). It received FDA 510(k) clearance on 2020-11-18 under 510(k) number K202800. 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 Pacific Plus PTA Catheter?

Pacific Plus PTA Catheter is a medical device that received FDA 510(k) clearance on 2020-11-18. The listed applicant is Medtronic Vascular,Inc(Formerly D.B.A Ev3 Inc.,Covidien, LLC). The 510(k) number is K202800.

When did Pacific Plus PTA Catheter receive FDA 510(k) clearance?

Pacific Plus PTA Catheter received FDA 510(k) clearance on 2020-11-18, under 510(k) number K202800.

Who is the listed applicant for Pacific Plus PTA Catheter?

The FDA 510(k) record lists Medtronic Vascular,Inc(Formerly D.B.A Ev3 Inc.,Covidien, LLC) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pacific Plus PTA Catheter?

The FDA product code for Pacific Plus PTA Catheter is LIT.

공식 출처

FDA 데이터베이스에서 보기 →

FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.

Pacific Plus PTA Catheter

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: LIT)

공식 출처