FDA 510(k)

coraForce and coraFlex Support Catheters

Número K: K201811 · 2020-10-26

Data da decisão2020-10-26

Código do produtoDQY

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

coraForce and coraFlex Support Catheters 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 2020-10-26 under 510(k) number K201811. 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 and coraFlex Support Catheters?

coraForce and coraFlex Support Catheters is a medical device that received FDA 510(k) clearance on 2020-10-26. The listed applicant is Reflow Medical, Inc.. The 510(k) number is K201811.

When did coraForce and coraFlex Support Catheters receive FDA 510(k) clearance?

coraForce and coraFlex Support Catheters received FDA 510(k) clearance on 2020-10-26, under 510(k) number K201811.

Who is the listed applicant for coraForce and coraFlex Support Catheters?

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 and coraFlex Support Catheters?

The FDA product code for coraForce and coraFlex Support Catheters is DQY.

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Outros registros que listam Reflow Medical, Inc. como candidato(a)

K262013Kiba CTO Crossing Catheter K251277CoraForce Microcatheter, CoraFlex Microcatheter K233350SINC Support Catheter K190393Wingman 14C Crossing Catheter K173661Wingman 35 Crossing Catheter K173662speX Support Catheter

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Fonte oficial

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