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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 K252238
Device Name CoroFlow Cardiovascular System
Applicant
Coroventis Research AB
Ulls Väg 29a
Uppsala,  SE 75651
Applicant Contact Johan Svanerud
Correspondent
Coroventis Research AB
Ulls Väg 29a
Uppsala,  SE 75651
Correspondent Contact Johan Svanerud
Regulation Number870.1425
Classification Product Code
DQK  
Subsequent Product Code
OUG  
Date Received07/17/2025
Decision Date 10/24/2025
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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