HeartFlow, Inc. - FDA 510(k) Cleared Devices
7
Total
7
Cleared
0
Denied
FDA 510(k) cleared devices by HeartFlow, Inc. Cardiovascular ✕
6 devices
Cleared
Oct 14, 2022
HeartFlow Analysis
Cardiovascular
308d
Cleared
Jan 08, 2021
HeartFlow Analysis
Cardiovascular
57d
Cleared
Aug 15, 2019
HeartFlow FFRct Analysis
Cardiovascular
128d
Cleared
Dec 06, 2018
FFRct
Cardiovascular
129d
Cleared
Aug 24, 2016
FFRct
Cardiovascular
57d
Cleared
Jan 13, 2016
FFRct
Cardiovascular
113d