Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 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.

Frequently Asked Questions

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.

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.

↑