FDA 510(k)

Vivio® LVEDP System

K-Number: K223905 · 2023-10-06

Decision Date2023-10-06

Product CodeQUO

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Vivio® LVEDP System is the device name listed in this FDA 510(k) record. The listed applicant is Avicena, LLC. It received FDA 510(k) clearance on 2023-10-06 under 510(k) 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. The listed applicant is Avicena, LLC. The 510(k) number is K223905.

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

Vivio® LVEDP System received FDA 510(k) clearance on 2023-10-06, under 510(k) number K223905.

Who is the listed applicant for Vivio® LVEDP System?

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

What is the FDA product code for Vivio® LVEDP System?

The FDA product code for Vivio® LVEDP System is QUO.

Other records listing Avicena, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K183710Vivio System

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Official Source

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