FDA 510(k)

True Flow Valvuloplasty Perfusion Catheter

N.º K: K152613 · 2016-01-19

Fecha de decisión2016-01-19

Código de productoOZT

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

True Flow Valvuloplasty Perfusion Catheter is the device name listed in this FDA 510(k) record. The listed applicant is C.R. Bard, Inc.. It received FDA 510(k) clearance on 2016-01-19 under 510(k) number K152613. The device is classified under product code OZT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the True Flow Valvuloplasty Perfusion Catheter?

True Flow Valvuloplasty Perfusion Catheter is a medical device that received FDA 510(k) clearance on 2016-01-19. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K152613.

When did True Flow Valvuloplasty Perfusion Catheter receive FDA 510(k) clearance?

True Flow Valvuloplasty Perfusion Catheter received FDA 510(k) clearance on 2016-01-19, under 510(k) number K152613.

Who is the listed applicant for True Flow Valvuloplasty Perfusion Catheter?

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

What is the FDA product code for True Flow Valvuloplasty Perfusion Catheter?

The FDA product code for True Flow Valvuloplasty Perfusion Catheter is OZT.

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Fuente oficial

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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.