510(k) K253509 ยท KRA Catheter, Continuous Flush
TriSalus TriNav Advance Infusion System
| Applicant | Trisalus Life Sciences, Westminster CO, US |
| Decision | Substantially Equivalent, Sep 21, 2026 |
| Received | Nov 5, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253509
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.