FDA 510(k)

Zenysis Short-Term Dialysis Catheter

N.º K: K153190 · 2016-01-05

Fecha de decisión2016-01-05

Código de productoMPB

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Zenysis Short-Term Dialysis 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 2016-01-05 under 510(k) number K153190. The device is classified under product code MPB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Zenysis Short-Term Dialysis Catheter?

Zenysis Short-Term Dialysis Catheter is a medical device that received FDA 510(k) clearance on 2016-01-05. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K153190.

When did Zenysis Short-Term Dialysis Catheter receive FDA 510(k) clearance?

Zenysis Short-Term Dialysis Catheter received FDA 510(k) clearance on 2016-01-05, under 510(k) number K153190.

Who is the listed applicant for Zenysis Short-Term Dialysis 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 Zenysis Short-Term Dialysis Catheter?

The FDA product code for Zenysis Short-Term Dialysis Catheter is MPB.

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