Company ยท US
HeartFlow, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2014 to 2025. Name variants (Inc, Corp, punctuation) are merged.
8510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| PJA | Coronary Vascular Physiologic Simulation Software | 8 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 18, 2025 | K250902 | HeartFlow Analysis HeartFlow, Inc. | PJA |
| Oct 14, 2022 | K213857 | HeartFlow Analysis HeartFlow, Inc. | PJA |
| Jan 8, 2021 | K203329 | HeartFlow Analysis HeartFlow, Inc. | PJA |
| Aug 15, 2019 | K190925 | HeartFlow FFRct Analysis HeartFlow, Inc. | PJA |
| Dec 6, 2018 | K182035 | FFRct HeartFlow, Inc. | PJA |
| Aug 24, 2016 | K161772 | FFRct HeartFlow, Inc. | PJA |
| Jan 13, 2016 | K152733 | FFRct HeartFlow, Inc. | PJA |
| Nov 26, 2014 | DEN130045 | HEARTFLOW FFRCT Heartflow | PJA |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||