FDA 510(k)

M-CATH Microcatheter

K-번호: K171176 · 2017-09-15

결정일2017-09-15

제품 코드DQY

자문 위원회CV

결정Substantially Equivalent

기기 요약

M-CATH Microcatheter is the device name listed in this FDA 510(k) record. The listed applicant is Acrostak (Schweiz) AG. It received FDA 510(k) clearance on 2017-09-15 under 510(k) number K171176. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the M-CATH Microcatheter?

M-CATH Microcatheter is a medical device that received FDA 510(k) clearance on 2017-09-15. The listed applicant is Acrostak (Schweiz) AG. The 510(k) number is K171176.

When did M-CATH Microcatheter receive FDA 510(k) clearance?

M-CATH Microcatheter received FDA 510(k) clearance on 2017-09-15, under 510(k) number K171176.

Who is the listed applicant for M-CATH Microcatheter?

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

What is the FDA product code for M-CATH Microcatheter?

The FDA product code for M-CATH Microcatheter is DQY.

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M-CATH Microcatheter

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: DQY)

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