# K193107: TriSalus Infusion System

- Pathway: 510(k) (Traditional)
- Applicant: Trisalus Life Sciences
- Decided: Dec 3, 2019 after 25 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: 7 generations back to K003105 (2001). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171355: Surefire Precision Infusion System, Surefire Medical, Inc. (2017) Summary page 4.

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

Source page: https://510kreport.com/device/K193107
Methodology: https://510kreport.com/methodology