510(k) K250659 · EZD Catheter, Straight
LoFric Origo
| Applicant | Wellspect AB, Mölndal, SE |
| Decision | Substantially Equivalent, Sep 26, 2025 |
| Received | Mar 5, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250659
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.