510(k) K190925 ยท PJA Coronary Vascular Physiologic Simulation Software
HeartFlow FFRct Analysis
| Applicant | HeartFlow, Inc., Redwood City CA, US |
| Decision | Substantially Equivalent, Aug 15, 2019 |
| Received | Apr 9, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190925
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.