# K230957: TriSalus TriNav® LV Infusion System

- Pathway: 510(k) (Traditional)
- Applicant: Trisalus Life Sciences
- Decided: May 2, 2023 after 28 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: 8 generations back to K003105 (2001). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180677: Surefire Spark Infusion System, Surefire Medical, Inc. (2018) Summary page 4.

## Most influential descendants
- K253509: TriSalus TriNav Advance Infusion System (2026), 0 descendants of its own

## Indications for use
The TriSalus TriNav® LV 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/K230957
Methodology: https://510kreport.com/methodology