Clearance Summary
HEARTFLOW FFRCT received FDA 510(k) clearance under submission number DEN130045, sponsored by Heartflow. The device was reviewed via the Direct premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2014-11-26.
- Submission: DEN130045
- Applicant / Sponsor: Heartflow
- Clearance pathway: Direct
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1415
- Decision date: 2014-11-26
Classification & Regulation
This clearance is catalogued under FDA product code PJA and 21 CFR 870.1415, within the Cardiovascular review panel as a Class II device.