# TriSalus TriNav Advance Infusion System (K253509): 510(k) cleared for Trisalus Life Sciences

**Predicate Speed & CAPA Advisory Opportunity Score:** 66/100

| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K253509 |
| Device | TriSalus TriNav Advance Infusion System |
| Applicant | Trisalus Life Sciences |
| Specialty / panel | Cardiovascular |
| Product code | KRA |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2025-11-05 |
| Decision date | 2026-09-21 |
| Review time (days) | 320 |
| Third-party review | Yes |
| Applicant location | Westminster, CO, US |

## Why this score
- A long 320-day review suggests additional-information requests: a firm likely to value regulatory help next time.
- Reviewed through the third-party program.
- Posted 45 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253509). Last refreshed: 2026-11-04T09:16:12.111Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.