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FDA 510(k)

CorVista® System

K-Number: K232686 · 2023-09-08

ApplicantCorvista Health, Inc.
Decision Date2023-09-08
Product CodeQXX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

What is the CorVista® System?

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

When was CorVista® System approved by the FDA?

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

What company makes CorVista® System?

CorVista® System is manufactured by Corvista Health, Inc..

What is the FDA product code for CorVista® System?

The FDA product code for CorVista® System is QXX.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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