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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 K213857
Device Name HeartFlow Analysis
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  
Subsequent Product Code
LLZ  
Date Received12/10/2021
Decision Date 10/14/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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