510(k) K251468 ยท EZD Catheter, Straight
Sleeved IC 3 Family Sleeved IC 3 SWT (name not finalized) Sleeved IC 3 Pocket (name not finalized) Sleeved IC 3 Plus (name not finalized) Sleeved IC 3 Plus Pocket (name not finalized) (N/A)
| Applicant | Hollister Incorporated, Libertyville IL, US |
| Decision | Substantially Equivalent, Oct 3, 2025 |
| Received | May 13, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251468
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.