FDA 510(k)

8F FlowGate2 Balão Guia Cateter

Número K: K153729 · 2016-01-27

Data da decisão2016-01-27

Código do produtoDQY

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

8F FlowGate2 Balloon Guide Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Concentric Medical. It received FDA 510(k) clearance on 2016-01-27 under 510(k) number K153729. 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 8F FlowGate2 Balloon Guide Catheter?

8F FlowGate2 Balloon Guide Catheter is a medical device that received FDA 510(k) clearance on 2016-01-27. The listed applicant is Concentric Medical. The 510(k) number is K153729.

When did 8F FlowGate2 Balloon Guide Catheter receive FDA 510(k) clearance?

8F FlowGate2 Balloon Guide Catheter received FDA 510(k) clearance on 2016-01-27, under 510(k) number K153729.

Who is the listed applicant for 8F FlowGate2 Balloon Guide Catheter?

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

What is the FDA product code for 8F FlowGate2 Balloon Guide Catheter?

The FDA product code for 8F FlowGate2 Balloon Guide Catheter is DQY.

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