510(k) K182035 ยท PJA Coronary Vascular Physiologic Simulation Software
FFRct
| Applicant | HeartFlow, Inc., Redwood City CA, US |
| Decision | Substantially Equivalent, Dec 6, 2018 |
| Received | Jul 30, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K182035
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.