FDA 510(k)

Cardio Flow Peripheral Guide Wire

Número K: K213834 · 2022-03-18

Data da decisão2022-03-18

Código do produtoDQX

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Cardio Flow Peripheral Guide Wire is the device name listed in this FDA 510(k) record. The listed applicant is Cardio Flow Inc.,. It received FDA 510(k) clearance on 2022-03-18 under 510(k) number K213834. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Cardio Flow Peripheral Guide Wire?

Cardio Flow Peripheral Guide Wire is a medical device that received FDA 510(k) clearance on 2022-03-18. The listed applicant is Cardio Flow Inc.,. The 510(k) number is K213834.

When did Cardio Flow Peripheral Guide Wire receive FDA 510(k) clearance?

Cardio Flow Peripheral Guide Wire received FDA 510(k) clearance on 2022-03-18, under 510(k) number K213834.

Who is the listed applicant for Cardio Flow Peripheral Guide Wire?

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

What is the FDA product code for Cardio Flow Peripheral Guide Wire?

The FDA product code for Cardio Flow Peripheral Guide Wire is DQX.

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Outros registros que listam Cardio Flow Inc., como candidato(a)

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Dispositivos Relacionados (Código: DQX)

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Fonte oficial

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