FDA 510(k)

Mikro-Cath Pressure Catheter

Número K: K163376 · 2017-03-10

Data da decisão2017-03-10

Código do produtoDXO

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Mikro-Cath Pressure Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Millar, Inc.. It received FDA 510(k) clearance on 2017-03-10 under 510(k) number K163376. The device is classified under product code DXO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Mikro-Cath Pressure Catheter?

Mikro-Cath Pressure Catheter is a medical device that received FDA 510(k) clearance on 2017-03-10. The listed applicant is Millar, Inc.. The 510(k) number is K163376.

When did Mikro-Cath Pressure Catheter receive FDA 510(k) clearance?

Mikro-Cath Pressure Catheter received FDA 510(k) clearance on 2017-03-10, under 510(k) number K163376.

Who is the listed applicant for Mikro-Cath Pressure Catheter?

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

What is the FDA product code for Mikro-Cath Pressure Catheter?

The FDA product code for Mikro-Cath Pressure Catheter is DXO.

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