510(k) K180354 · KOD Catheter, Urological
UroGen Ureteral Catheter
| Applicant | Urogen Pharma, Ltd., RaAnana, IL |
| Decision | Substantially Equivalent, Oct 30, 2018 |
| Received | Feb 8, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180354
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.