FDA 510(k)

Penumbra System (Reperfusion Catheter RED 43)

Número K: K222808 · 2022-12-20

Data da decisão2022-12-20

Código do produtoNRY

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Penumbra System (Reperfusion Catheter RED 43) is the device name listed in this FDA 510(k) record. The listed applicant is Penumbra, Inc.. It received FDA 510(k) clearance on 2022-12-20 under 510(k) number K222808. The device is classified under product code NRY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Penumbra System (Reperfusion Catheter RED 43)?

Penumbra System (Reperfusion Catheter RED 43) is a medical device that received FDA 510(k) clearance on 2022-12-20. The listed applicant is Penumbra, Inc.. The 510(k) number is K222808.

When did Penumbra System (Reperfusion Catheter RED 43) receive FDA 510(k) clearance?

Penumbra System (Reperfusion Catheter RED 43) received FDA 510(k) clearance on 2022-12-20, under 510(k) number K222808.

Who is the listed applicant for Penumbra System (Reperfusion Catheter RED 43)?

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

What is the FDA product code for Penumbra System (Reperfusion Catheter RED 43)?

The FDA product code for Penumbra System (Reperfusion Catheter RED 43) is NRY.

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Fonte oficial

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