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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