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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 K161772
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 Received06/28/2016
Decision Date 08/24/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT01189331
NCT01233518
NCT01757678
Reviewed by Third Party No
Combination Product No
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