FDA 510(k)

고급 혈류 시스템 1

K-번호: K172220 · 2017-08-17

신청자Terumo Cardiovascular Systems Corporation

결정일2017-08-17

제품 코드DTQ

자문 위원회CV

결정Substantially Equivalent

기기 요약

Advanced Perfusion System 1 is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Cardiovascular Systems Corporation. It received FDA 510(k) clearance on 2017-08-17 under 510(k) number K172220. The device is classified under product code DTQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Advanced Perfusion System 1?

Advanced Perfusion System 1 is a medical device that received FDA 510(k) clearance on 2017-08-17. The listed applicant is Terumo Cardiovascular Systems Corporation. The 510(k) number is K172220.

When did Advanced Perfusion System 1 receive FDA 510(k) clearance?

Advanced Perfusion System 1 received FDA 510(k) clearance on 2017-08-17, under 510(k) number K172220.

Who is the listed applicant for Advanced Perfusion System 1?

The FDA 510(k) record lists Terumo Cardiovascular Systems Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Advanced Perfusion System 1?

The FDA product code for Advanced Perfusion System 1 is DTQ.

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