HeartFlow, Inc. - FDA 510(k) Cleared Devices

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.

1 device has linked clinical trial registered on ClinicalTrials.gov. 1 submission has an FDA-authorized Predetermined Change Control Plan (PCCP), indicating AI or software-based device development.