FDA 510(k)

ViperCath XC Peripheral Exchange Catheter

Número K: K211251 · 2021-05-26

Data da decisão2021-05-26

Código do produtoDQY

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

ViperCath XC Peripheral Exchange Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Cardiovascular Systems, Inc.. It received FDA 510(k) clearance on 2021-05-26 under 510(k) number K211251. 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 ViperCath XC Peripheral Exchange Catheter?

ViperCath XC Peripheral Exchange Catheter is a medical device that received FDA 510(k) clearance on 2021-05-26. The listed applicant is Cardiovascular Systems, Inc.. The 510(k) number is K211251.

When did ViperCath XC Peripheral Exchange Catheter receive FDA 510(k) clearance?

ViperCath XC Peripheral Exchange Catheter received FDA 510(k) clearance on 2021-05-26, under 510(k) number K211251.

Who is the listed applicant for ViperCath XC Peripheral Exchange Catheter?

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

What is the FDA product code for ViperCath XC Peripheral Exchange Catheter?

The FDA product code for ViperCath XC Peripheral Exchange Catheter is DQY.

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Fonte oficial

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