Vivio® LVEDP System
K-Number: K223905 · 2023-10-06
ApplicantAvicena, LLC
Decision Date2023-10-06
Product CodeQUO
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Vivio® LVEDP System is a medical device manufactured by Avicena, LLC. It received FDA 510(k) clearance on 2023-10-06 under approval number K223905. The device is classified under product code QUO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Vivio® LVEDP System?
Vivio® LVEDP System is a medical device that received FDA 510(k) clearance on 2023-10-06. It is manufactured by Avicena, LLC. The 510(k) number is K223905.
When was Vivio® LVEDP System approved by the FDA?
Vivio® LVEDP System received FDA 510(k) clearance on 2023-10-06, under approval number K223905.
What company makes Vivio® LVEDP System?
Vivio® LVEDP System is manufactured by Avicena, LLC.
What is the FDA product code for Vivio® LVEDP System?
The FDA product code for Vivio® LVEDP System is QUO.
Other Devices by Avicena, LLC
Related Devices (Code: QUO)
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.