FDA 510(k)

Twin-Pass Dual Access Catheter

Número K: K193119 · 2020-06-29

Data da decisão2020-06-29

Código do produtoDQY

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Twin-Pass Dual Access Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Vascular Solutions, LLC. It received FDA 510(k) clearance on 2020-06-29 under 510(k) number K193119. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Twin-Pass Dual Access Catheter?

Twin-Pass Dual Access Catheter is a medical device that received FDA 510(k) clearance on 2020-06-29. The listed applicant is Vascular Solutions, LLC. The 510(k) number is K193119.

When did Twin-Pass Dual Access Catheter receive FDA 510(k) clearance?

Twin-Pass Dual Access Catheter received FDA 510(k) clearance on 2020-06-29, under 510(k) number K193119.

Who is the listed applicant for Twin-Pass Dual Access Catheter?

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

What is the FDA product code for Twin-Pass Dual Access Catheter?

The FDA product code for Twin-Pass Dual Access Catheter is DQY.

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Fonte oficial

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