510(k) K203329
K203329 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 January 8, 2021. 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
- January 8, 2021
- Date Received
- November 12, 2020
- 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.