FDA 510(k)

Pinpoint GT Introducer Needle

Número K: K162769 · 2016-11-04

Data da decisão2016-11-04

Código do produtoDYB

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Pinpoint GT Introducer Needle 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 2016-11-04 under 510(k) number K162769. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Pinpoint GT Introducer Needle?

Pinpoint GT Introducer Needle is a medical device that received FDA 510(k) clearance on 2016-11-04. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K162769.

When did Pinpoint GT Introducer Needle receive FDA 510(k) clearance?

Pinpoint GT Introducer Needle received FDA 510(k) clearance on 2016-11-04, under 510(k) number K162769.

Who is the listed applicant for Pinpoint GT Introducer Needle?

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 Pinpoint GT Introducer Needle?

The FDA product code for Pinpoint GT Introducer Needle is DYB.

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