# K160662: Surefire Infusion System

- Pathway: 510(k) (Special)
- Applicant: Surefire Medical, Inc.
- Decided: Mar 11, 2016 after 2 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K003105 (2001). 7 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143588: Surefire Infusion System 021, Surefire Medical, Inc. (2015) Summary page 4.

## Most influential descendants
- K171355: Surefire Precision Infusion System (2017), 4 descendants of its own
- K180677: Surefire Spark Infusion System (2018), 2 descendants of its own
- K230957: TriSalus TriNav® LV Infusion System (2023), 1 descendant of its own
- K253509: TriSalus TriNav Advance Infusion System (2026), 0 descendants of its own
- K193107: TriSalus Infusion System (2019), 0 descendants of its own

## Indications for use
The Surefire 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/K160662
Methodology: https://510kreport.com/methodology