FDA 510(k)

CoraForce Microcatheter, CoraFlex Microcatheter

Número K: K251277 · 2025-08-22

Data da decisão2025-08-22

Código do produtoDQY

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

CoraForce Microcatheter, CoraFlex Microcatheter is the device name listed in this FDA 510(k) record. The listed applicant is Reflow Medical, Inc.. It received FDA 510(k) clearance on 2025-08-22 under 510(k) number K251277. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the CoraForce Microcatheter, CoraFlex Microcatheter?

CoraForce Microcatheter, CoraFlex Microcatheter is a medical device that received FDA 510(k) clearance on 2025-08-22. The listed applicant is Reflow Medical, Inc.. The 510(k) number is K251277.

When did CoraForce Microcatheter, CoraFlex Microcatheter receive FDA 510(k) clearance?

CoraForce Microcatheter, CoraFlex Microcatheter received FDA 510(k) clearance on 2025-08-22, under 510(k) number K251277.

Who is the listed applicant for CoraForce Microcatheter, CoraFlex Microcatheter?

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

What is the FDA product code for CoraForce Microcatheter, CoraFlex Microcatheter?

The FDA product code for CoraForce Microcatheter, CoraFlex Microcatheter is DQY.

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Fonte oficial

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