# Trisalus Life Sciences

- Location (FDA's records): Westminster, CO
- FDA decisions: 4 (2019–2026): 4 510(k) clearances
- Product codes: KRA (3), DQY (1)
- 510(k) review time since 2016: median 27 days, against 124 for FDA's reviews in the same codes and years (3 of 4 faster)
- Predicates its devices cite: 4 (1 its own); citations of its devices by later devices: 1 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Surefire Medical, Inc.: 3 (https://510kreport.com/company/surefire-medical)

## Its most-cited devices
- K230957: TriSalus TriNav® LV Infusion System (2023), cited by 1

## Recent decisions
- K253509: TriSalus TriNav Advance Infusion System (Sep 21, 2026)
- K233858: TriSalus TriGuideTM Guiding Catheter (Dec 27, 2023)
- K230957: TriSalus TriNav® LV Infusion System (May 2, 2023)
- K193107: TriSalus Infusion System (Dec 3, 2019)

Source page: https://510kreport.com/company/trisalus-life-sciences