FDA 510(k)

FlowSaver Blood Return System (80-101)

Número K: K231782 · 2023-07-14

Data da decisão2023-07-14

Código do produtoCAC

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

FlowSaver Blood Return System (80-101) is the device name listed in this FDA 510(k) record. The listed applicant is Inari Medical, Inc.. It received FDA 510(k) clearance on 2023-07-14 under 510(k) number K231782. The device is classified under product code CAC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the FlowSaver Blood Return System (80-101)?

FlowSaver Blood Return System (80-101) is a medical device that received FDA 510(k) clearance on 2023-07-14. The listed applicant is Inari Medical, Inc.. The 510(k) number is K231782.

When did FlowSaver Blood Return System (80-101) receive FDA 510(k) clearance?

FlowSaver Blood Return System (80-101) received FDA 510(k) clearance on 2023-07-14, under 510(k) number K231782.

Who is the listed applicant for FlowSaver Blood Return System (80-101)?

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

What is the FDA product code for FlowSaver Blood Return System (80-101)?

The FDA product code for FlowSaver Blood Return System (80-101) is CAC.

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Fonte oficial

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