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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
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