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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Peripheral Mechanical Thrombectomy With Aspiration
510(k) Number K253730
Device Name RoVo Mechanical Thrombectomy System
Applicant
Verge Medical, Inc.
747 Camden Ave.
Suite A
Campbell,  CA  95008
Applicant Contact Michael Buck
Correspondent
Bridge City Regulatory, LLC
5331 S Macadam Ave.
Suite 258, Pmb #708
Portland,  OR  97239
Correspondent Contact Rey Jacinto
Regulation Number870.5150
Classification Product Code
QEW  
Subsequent Product Code
DQO  
Date Received11/24/2025
Decision Date 01/21/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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