FDA 510(k)

WIRION Embolic Protection System

Número K: K210282 · 2021-03-03

Data da decisão2021-03-03

Código do produtoNTE

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

WIRION Embolic Protection System 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 2021-03-03 under 510(k) number K210282. The device is classified under product code NTE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the WIRION Embolic Protection System?

WIRION Embolic Protection System is a medical device that received FDA 510(k) clearance on 2021-03-03. The listed applicant is Cardiovascular Systems, Inc.. The 510(k) number is K210282.

When did WIRION Embolic Protection System receive FDA 510(k) clearance?

WIRION Embolic Protection System received FDA 510(k) clearance on 2021-03-03, under 510(k) number K210282.

Who is the listed applicant for WIRION Embolic Protection System?

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 WIRION Embolic Protection System?

The FDA product code for WIRION Embolic Protection System is NTE.

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Fonte oficial

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