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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 coronary vascular physiologic simulation software
De Novo Number DEN130045
Device Name HEARTFLOW FFRCT
Requester
heartflow
1400 seaport blvd
building b
redwood city,  CA  94063
Contact dustin michaels
Regulation Number870.1415
Classification Product Code
PJA  
Date Received11/04/2013
Decision Date 11/26/2014
Decision granted (DENG)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
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