FDA 510(k)

Balão Guia 091

Número K: K231629 · 2023-10-31

Data da decisão2023-10-31

Código do produtoDQY

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

091 Balloon Guide Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Eosolutions, Corp.. It received FDA 510(k) clearance on 2023-10-31 under 510(k) number K231629. 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 091 Balloon Guide Catheter?

091 Balloon Guide Catheter is a medical device that received FDA 510(k) clearance on 2023-10-31. The listed applicant is Eosolutions, Corp.. The 510(k) number is K231629.

When did 091 Balloon Guide Catheter receive FDA 510(k) clearance?

091 Balloon Guide Catheter received FDA 510(k) clearance on 2023-10-31, under 510(k) number K231629.

Who is the listed applicant for 091 Balloon Guide Catheter?

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

What is the FDA product code for 091 Balloon Guide Catheter?

The FDA product code for 091 Balloon Guide Catheter is DQY.

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