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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coronary Vascular Physiologic Simulation Software
510(k) Number K182035
Device Name FFRct
Applicant
HeartFlow, Inc
1400 Seaport Boulevard
Building B
Redwood City,  CA  94063
Applicant Contact Windi Hary
Correspondent
HeartFlow, Inc
1400 Seaport Boulevard
Building B
Redwood City,  CA  94063
Correspondent Contact Windi Hary
Regulation Number870.1415
Classification Product Code
PJA  
Date Received07/30/2018
Decision Date 12/06/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Clinical Trials NCT01189331
NCT01233518
NCT01757678
Reviewed by Third Party No
Combination Product No
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