PJA — Coronary Vascular Physiologic Simulation Software Class II
FDA product code PJA covers "Coronary Vascular Physiologic Simulation Software", a Class II medical device regulated under 21 CFR 870.1415. Submissions are reviewed by the Cardiovascular panel. At least 9 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PJA
- Device Class
- Class II
- Regulation Number
- 870.1415
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Definition
A coronary vascular physiologic simulation software device is intended to aid in the identification of functionally significant cardiovascular disease.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K250902 | Heartflow | HeartFlow Analysis | Jul 18, 2025 |
| K213857 | Heartflow | HeartFlow Analysis | Oct 14, 2022 |
| K213657 | Keyamed Na | DEEPVESSEL FFR | Apr 1, 2022 |
| K203329 | Heartflow | HeartFlow Analysis | Jan 8, 2021 |
| K190925 | Heartflow | HeartFlow FFRct Analysis | Aug 15, 2019 |
| K182035 | Heartflow | FFRct | Dec 6, 2018 |
| K161772 | Heartflow | FFRct | Aug 24, 2016 |
| K152733 | Heartflow | FFRct | Jan 13, 2016 |
| DEN130045 | Heartflow | HEARTFLOW FFRCT | Nov 26, 2014 |