510(k) K250910 · EZN Dilator, Catheter, Ureteral
Optilume® High Pressure Urological Balloon Dilation Catheter
| Applicant | Urotronic, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, May 22, 2025 |
| Received | Mar 26, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250910
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.