510(k) K213857 ยท PJA Coronary Vascular Physiologic Simulation Software
HeartFlow Analysis
| Applicant | HeartFlow, Inc., Redwood City CA, US |
| Decision | Substantially Equivalent, Oct 14, 2022 |
| Received | Dec 10, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213857
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.