FDA 510(k)

PW Guidewires

Número K: K152497 · 2016-01-22

Data da decisão2016-01-22

Código do produtoDQX

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

PW Guidewires is the device name listed in this FDA 510(k) record. The listed applicant is Tatara Vascular, LLC. It received FDA 510(k) clearance on 2016-01-22 under 510(k) number K152497. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the PW Guidewires?

PW Guidewires is a medical device that received FDA 510(k) clearance on 2016-01-22. The listed applicant is Tatara Vascular, LLC. The 510(k) number is K152497.

When did PW Guidewires receive FDA 510(k) clearance?

PW Guidewires received FDA 510(k) clearance on 2016-01-22, under 510(k) number K152497.

Who is the listed applicant for PW Guidewires?

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

What is the FDA product code for PW Guidewires?

The FDA product code for PW Guidewires is DQX.

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