FDA 510(k)

QuikPass Catheter

Número K: K214106 · 2022-01-28

Data da decisão2022-01-28

Código do produtoDQY

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

QuikPass Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Traverse Vascular, Inc.. It received FDA 510(k) clearance on 2022-01-28 under 510(k) number K214106. 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 QuikPass Catheter?

QuikPass Catheter is a medical device that received FDA 510(k) clearance on 2022-01-28. The listed applicant is Traverse Vascular, Inc.. The 510(k) number is K214106.

When did QuikPass Catheter receive FDA 510(k) clearance?

QuikPass Catheter received FDA 510(k) clearance on 2022-01-28, under 510(k) number K214106.

Who is the listed applicant for QuikPass Catheter?

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

What is the FDA product code for QuikPass Catheter?

The FDA product code for QuikPass Catheter is DQY.

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Fonte oficial

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