510(k) K260999 · EZD Catheter, Straight
LoFric Elle Pro
| Applicant | Wellspect AB, Mölndal, SE |
| Decision | Substantially Equivalent, Apr 24, 2026 |
| Received | Mar 26, 2026 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K260999
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.