FDA 510(k)

FLEX Vessel Prep System

K-번호: K202187 · 2020-09-11

결정일2020-09-11

제품 코드PNO

자문 위원회CV

결정Substantially Equivalent

기기 요약

FLEX Vessel Prep System is the device name listed in this FDA 510(k) record. The listed applicant is Venturemed Group, Inc.. It received FDA 510(k) clearance on 2020-09-11 under 510(k) number K202187. The device is classified under product code PNO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the FLEX Vessel Prep System?

FLEX Vessel Prep System is a medical device that received FDA 510(k) clearance on 2020-09-11. The listed applicant is Venturemed Group, Inc.. The 510(k) number is K202187.

When did FLEX Vessel Prep System receive FDA 510(k) clearance?

FLEX Vessel Prep System received FDA 510(k) clearance on 2020-09-11, under 510(k) number K202187.

Who is the listed applicant for FLEX Vessel Prep System?

The FDA 510(k) record lists Venturemed Group, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FLEX Vessel Prep System?

The FDA product code for FLEX Vessel Prep System is PNO.

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FLEX Vessel Prep System

기기 요약

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관련 임상시험

관련 기기 (코드: PNO)

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