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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Programmable
510(k) Number K243812
Device Name Volta AF-Xplorer
Applicant
Volta Medical
65 Avenue Jules Cantini
Marseille,  FR 13006
Applicant Contact Paola Milpied
Correspondent
Hogan Lovells US LLP
555 Thirteenth Street, NW
Washington,  DC  20004
Correspondent Contact Kristin Duggan
Regulation Number870.1425
Classification Product Code
DQK  
Date Received12/11/2024
Decision Date 05/09/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT04702451
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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