FDA 510(k)

CorVista® System

Número K: K232686 · 2023-09-08

Data da decisão2023-09-08

Código do produtoQXX

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

CorVista® System is the device name listed in this FDA 510(k) record. The listed applicant is Corvista Health, Inc.. It received FDA 510(k) clearance on 2023-09-08 under 510(k) number K232686. The device is classified under product code QXX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the CorVista® System?

CorVista® System is a medical device that received FDA 510(k) clearance on 2023-09-08. The listed applicant is Corvista Health, Inc.. The 510(k) number is K232686.

When did CorVista® System receive FDA 510(k) clearance?

CorVista® System received FDA 510(k) clearance on 2023-09-08, under 510(k) number K232686.

Who is the listed applicant for CorVista® System?

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

What is the FDA product code for CorVista® System?

The FDA product code for CorVista® System is QXX.

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