510(k) K223809 ยท QQI Interventional Cardiovascular Implant Simulation Software Device
PrecisionTAVI (v1.1)
| Applicant | Dasi Simulations, Dublin OH, US |
| Decision | Substantially Equivalent, May 30, 2023 |
| Received | Dec 20, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223809
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.