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FDA 510(k) Applications for Medical Device Product Code "PJA"
FDA 510(k) Number
Applicant
Device Name
Decision Date
DEN130045
HEARTFLOW
HEARTFLOW FFRCT
11/26/2014
K182035
HeartFlow, Inc
FFRct
12/06/2018
K161772
HEARTFLOW, INC.
FFRct
08/24/2016
K152733
HEARTFLOW, INC.
FFRct
01/13/2016
K203329
HeartFlow, Inc.
HeartFlow Analysis
01/08/2021
K213857
HeartFlow, Inc.
HeartFlow Analysis
10/14/2022
K190925
HeartFlow, Inc.
HeartFlow FFRct Analysis
08/15/2019
K213657
KeyaMed NA Inc.
DEEPVESSEL FFR
04/01/2022
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