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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interventional Cardiovascular Implant Simulation Software Device
510(k) Number K250635
Device Name FEops HEARTguide Simulation Application
Applicant
Feops NV
Technologiepark- Zwijnaarde 122
Gent,  BE 9052
Applicant Contact Franky Dubois
Correspondent
Feops NV
Technologiepark- Zwijnaarde 122
Gent,  BE 9052
Correspondent Contact Franky Dubois
Regulation Number870.1405
Classification Product Code
QQI  
Date Received03/03/2025
Decision Date 11/25/2025
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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