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FDA 510(k) Applications Submitted by HEARTFLOW, INC.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K190925
04/09/2019
HeartFlow FFRct Analysis
HeartFlow, Inc.
K161772
06/28/2016
FFRct
HEARTFLOW, INC.
K152733
09/22/2015
FFRct
HEARTFLOW, INC.
K203329
11/12/2020
HeartFlow Analysis
HeartFlow, Inc.
K213857
12/10/2021
HeartFlow Analysis
HeartFlow, Inc.
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