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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 K251518
Device Name Volta AF-Xplorer II
Applicant
Volta Medical
65 Ave. Jules Cantini
Tour Mediterranee
Marseille,  FR 13006
Applicant Contact Paola Milpied
Correspondent
Hogan Lovells US LLP
555 Thirteenth St., NW
Washington, Dc,  DC  20004
Correspondent Contact Kristin Duggan
Regulation Number870.1425
Classification Product Code
DQK  
Date Received05/16/2025
Decision Date 09/12/2025
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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