510(k) K254051 ยท KRA Catheter, Continuous Flush
Extroducer Infusion Catheter System
| Applicant | SmartWise Sweden AB, Tullinge, SE |
| Decision | Substantially Equivalent, Sep 11, 2026 |
| Received | Dec 17, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K254051
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.