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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Adjunctive Heart Failure Status Indicator
510(k) Number K223905
Device Name Vivio® LVEDP System
Applicant
Avicena, LLC
117 E. Colorado Blvd., Suite 510
Pasadena,  CA  91105
Applicant Contact Sean Brady
Correspondent
Qserve Group, US
350 S. Main St. Suite 309
Doylestown,  PA  18901
Correspondent Contact Lorry Weaver
Regulation Number870.2200
Classification Product Code
QUO  
Date Received12/28/2022
Decision Date 10/06/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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