# K253509: TriSalus TriNav Advance Infusion System

- Pathway: 510(k) (Traditional)
- Applicant: Trisalus Life Sciences
- Decided: Sep 21, 2026 after 320 days
- Product code: KRA (Catheter, Continuous Flush)
- Device class: 2
- Regulation: 21 CFR 870.1210
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K003105 (2001). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230957: TriSalus TriNav® LV Infusion System, Trisalus Life Sciences (2023) Summary page 5.

## Indications for use
The TriSalus TriNav Advance Infusion System is intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the peripheral vascular system.

Source page: https://510kreport.com/device/K253509
Methodology: https://510kreport.com/methodology