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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name interventional cardiovascular implant simulation software device
De Novo Number DEN200030
Device Name FEops HEARTguide
Requester
feops nv
technologiepark 122
gent-zwijnaarde,  BE 9052
Contact sofie van cauter
Regulation Number870.1405
Classification Product Code
QQI  
Date Received05/07/2020
Decision Date 09/08/2021
Decision granted (DENG)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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