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Vivio® LVEDP System — Avicena, LLC (510(k) K223905)

Vivio® LVEDP System — Avicena, LLC (510(k) K223905) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: Vivio® LVEDP System; Applicant: Avicena, LLC; Clearance track: 510(k).

Device nameVivio® LVEDP System
ApplicantAvicena, LLC
Clearance track510(k)
Submission numberK223905
DecisionSubstantially Equivalent
Decision date2023-10-06
Date received2022-12-28
Product codeQUO
Device class2
Medical specialtyCardiovascular
Applicant locationCA, US
SourceopenFDA device

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