510(k) K250635 ยท QQI Interventional Cardiovascular Implant Simulation Software Device
FEops HEARTguide Simulation Application
| Applicant | Feops NV, Gent, BE |
| Decision | Substantially Equivalent, Nov 25, 2025 |
| Received | Mar 3, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250635
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.