510(k) K213857
K213857 is an FDA 510(k) premarket notification submitted by HeartFlow, Inc. for the device "HeartFlow Analysis". The FDA issued a decision of Substantially Equivalent on October 14, 2022. The device falls under product code PJA (Coronary Vascular Physiologic Simulation Software), a Class II device regulated under 21 CFR 870.1415. HeartFlow, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 14, 2022
- Date Received
- December 10, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Coronary Vascular Physiologic Simulation Software
- Device Class
- Class II
- Regulation Number
- 870.1415
- Review Panel
- CV
- Submission Type
A coronary vascular physiologic simulation software device is intended to aid in the identification of functionally significant cardiovascular disease.