FDA 510(k)

Phenom 27 Catheter

Número K: K180959 · 2018-06-11

Data da decisão2018-06-11

Código do produtoDQY

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Phenom 27 Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Cathera, Inc.. It received FDA 510(k) clearance on 2018-06-11 under 510(k) number K180959. 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 Phenom 27 Catheter?

Phenom 27 Catheter is a medical device that received FDA 510(k) clearance on 2018-06-11. The listed applicant is Cathera, Inc.. The 510(k) number is K180959.

When did Phenom 27 Catheter receive FDA 510(k) clearance?

Phenom 27 Catheter received FDA 510(k) clearance on 2018-06-11, under 510(k) number K180959.

Who is the listed applicant for Phenom 27 Catheter?

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

What is the FDA product code for Phenom 27 Catheter?

The FDA product code for Phenom 27 Catheter is DQY.

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