510(k) K230165 · EZD Catheter, Straight
Luja Coudé (20118 Male CH8 - small packaging (Pocket size)), Luja Coudé (20111 Male CH10 - small packaging (Pocket size)), Luja Coudé (20112 Male CH12 - small packaging (Pocket size)), Luja Coudé (20114 Male CH14 - small packaging (Pocket size)), Luja Coudé (20101 Male CH10 - large packaging), Luja
| Applicant | Coloplast, Plymouth MN, US |
| Decision | Substantially Equivalent, Aug 25, 2023 |
| Received | Jan 20, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230165
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.