510(k) K250902 ยท PJA Coronary Vascular Physiologic Simulation Software
HeartFlow Analysis
| Applicant | HeartFlow, Inc., Mountain View CA, US |
| Decision | Substantially Equivalent, Jul 18, 2025 |
| Received | Mar 26, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250902
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.