HeartFlow, Inc. - FDA 510(k) Cleared Devices
7
Total
7
Cleared
0
Denied
HeartFlow, Inc. has 7 FDA 510(k) cleared medical devices. Based in Redwood City, US.
Latest FDA clearance: Jul 2025. Active since 2016. Primary specialty: Cardiovascular.
Browse the FDA 510(k) cleared devices submitted by HeartFlow, Inc. Filter by specialty or product code using the sidebar.
FDA 510(k) cleared devices by HeartFlow, Inc.
7 devices
Cleared
Jul 18, 2025
HeartFlow Analysis
Radiology
114d
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