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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
Predetermined Change
Control Plan Authorized		 No
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