FDA 510(k)

BD Prevue II Peripheral Vascular Vascular Access System

Número K: K211193 · 2021-06-25

RequerenteBard Access Systems, Inc. (C.R. Bard, Inc.)

Data da decisão2021-06-25

Código do produtoIYO

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

BD Prevue II Peripheral Vascular Vascular Access System is the device name listed in this FDA 510(k) record. The listed applicant is Bard Access Systems, Inc. (C.R. Bard, Inc.). It received FDA 510(k) clearance on 2021-06-25 under 510(k) number K211193. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the BD Prevue II Peripheral Vascular Vascular Access System?

BD Prevue II Peripheral Vascular Vascular Access System is a medical device that received FDA 510(k) clearance on 2021-06-25. The listed applicant is Bard Access Systems, Inc. (C.R. Bard, Inc.). The 510(k) number is K211193.

When did BD Prevue II Peripheral Vascular Vascular Access System receive FDA 510(k) clearance?

BD Prevue II Peripheral Vascular Vascular Access System received FDA 510(k) clearance on 2021-06-25, under 510(k) number K211193.

Who is the listed applicant for BD Prevue II Peripheral Vascular Vascular Access System?

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

What is the FDA product code for BD Prevue II Peripheral Vascular Vascular Access System?

The FDA product code for BD Prevue II Peripheral Vascular Vascular Access System is IYO.

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Fonte oficial

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