TriSalus TriNav Advance Infusion System— 510(k) K253509
Substantially EquivalentTrisalus Life Sciences
FDA 510(k) clearance K253509 for TriSalus TriNav Advance Infusion System, Substantially Equivalent on 2026-09-21. Applicant: Trisalus Life Sciences. Device class: 2.
Summary
The TriSalus TriNav Advance Infusion System is filed under KRA, continuous-flush catheters. The record doesn't say which vessels or therapies it's meant for.
Class II, 21 CFR 870.1210. The Cardiovascular panel reviewed it as a Traditional 510(k).
Trisalus Life Sciences filed from Westminster, Colorado. Review took 320 days (November 5, 2025 to September 21, 2026). That count is calendar days, not FDA review days.
Clearance details
- Applicant
- Trisalus Life Sciences
- Product code
- Product code KRA
- Device class
- Class 2
- Regulation
- 21 CFR 870.1210
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Westminster, CO, US
Recent devices under product code KRA
view allMore clearances from Trisalus Life Sciences
view allAdverse events under product code KRA
product code KRA- Death
- 234
- Injury
- 1,029
- Malfunction
- 3,012
- Other
- 2
- Total
- 4,277
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.