# K110459: Surefire Infusion Catheter System

- Pathway: 510(k) (Traditional)
- Applicant: Surefire Medical, Inc.
- Decided: Jun 24, 2011 after 127 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: 2 generations back to K003105 (2001). 4 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090040: Radifocus Glidecath (or Radifocus Glidecath XP), Terumo Medical Corp. (2009) Summary page 3.
- K062126: Embocath Plus Infusion Microcatheter, Model Ecp-100 and Ecp-135, Biosphere Medical, Inc. (2006) Summary page 3.

## Most influential descendants
- K121677: Surefire HI-Flow Microcatheter (2012), 7 descendants of its own
- K143588: Surefire Infusion System 021 (2015), 6 descendants of its own
- 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

## Indications for use
The SUREFIRE TM INFUSION CATHETER 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/K110459
Methodology: https://510kreport.com/methodology