# K143588: Surefire Infusion System 021

- Pathway: 510(k) (Traditional)
- Applicant: Surefire Medical, Inc.
- Decided: Jan 12, 2015 after 25 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: 4 generations back to K003105 (2001). 6 ancestors in all.
6 later devices descend from it; 2 cite 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)
- K121677: Surefire HI-Flow Microcatheter, Surefire Medical, Inc. (2012) Summary page 4.

## Most influential descendants
- K160662: Surefire Infusion System (2016), 5 descendants of its own
- 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

## Indications for use
The Surefire Infusion System 021 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/K143588
Methodology: https://510kreport.com/methodology