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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheters, Transluminal Coronary Angioplasty, Percutaneous
510(k) Number K254022
Device Name FLASH Flex™ Aorto-Ostial Angioplasty 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 Reynier Jacinto
Regulation Number870.5100
Classification Product Code
LOX  
Date Received12/16/2025
Decision Date 04/02/2026
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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