FDA Product Code
FDA Product Code PJA — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.1415
510(k) Clearances — 10 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K262015 | Elucid FFR-IQ (B.1) | Elucid Bioimaging, Inc. | 2026-09-29 | Traditional | PDF ↗ |
| K250902 | HeartFlow Analysis | HeartFlow, Inc. | 2025-07-18 | Traditional | PDF ↗ |
| K213857 | HeartFlow Analysis | HeartFlow, Inc. | 2022-10-14 | Traditional | PDF ↗ |
| K213657 | DEEPVESSEL FFR | Keyamed Na, Inc. | 2022-04-01 | Traditional | PDF ↗ |
| K203329 | HeartFlow Analysis | HeartFlow, Inc. | 2021-01-08 | Traditional | PDF ↗ |
| K190925 | HeartFlow FFRct Analysis | HeartFlow, Inc. | 2019-08-15 | Traditional | PDF ↗ |
| K182035 | FFRct | HeartFlow, Inc. | 2018-12-06 | Special | PDF ↗ |
| K161772 | FFRct | HeartFlow, Inc. | 2016-08-24 | Traditional | PDF ↗ |
| K152733 | FFRct | HeartFlow, Inc. | 2016-01-13 | Traditional | PDF ↗ |
| DEN130045 | HEARTFLOW FFRCT | Heartflow | 2014-11-26 | Direct | — |
Product code PJA · Class II · Cardiovascular. Data: openFDA.