HeartFlow Analysis

Coronary Vascular Physiologic Simulation Software

HeartFlow, Inc.

The following data is part of a premarket notification filed by Heartflow, Inc. with the FDA for Heartflow Analysis.

Pre-market Notification Details

Device IDK203329
510k NumberK203329
Device Name:HeartFlow Analysis
ClassificationCoronary Vascular Physiologic Simulation Software
Applicant HeartFlow, Inc. 1400 Seaport Boulevard, Building B Redwood City,  CA  94063
ContactWindi Hary
CorrespondentWindi Hary
HeartFlow, Inc. 1400 Seaport Boulevard, Building B Redwood City,  CA  94063
Product CodePJA  
CFR Regulation Number870.1415 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-12
Decision Date2021-01-08

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