HeartFlow Analysis— 510(k) K250902
Substantially EquivalentHeartFlow, Inc.
FDA 510(k) clearance K250902 for HeartFlow Analysis, Substantially Equivalent on 2025-07-18. Applicant: HeartFlow, Inc.. Device class: 2.
Clearance details
- Applicant
- HeartFlow, Inc.
- Product code
- Code PJA
- Device class
- Class 2
- Regulation
- 21 CFR 870.1415
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mountain View, CA, US
Recent devices under product code PJA
view allMore clearances from HeartFlow, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.