# K140034: Surefire Guiding Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Surefire Medical, Inc.
- Decided: Feb 26, 2014 after 50 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K981198 (1998). 4 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030779: 5F Medtronic Launcher Guide Catheter, Medtronic Vascular (2003) Summary page 1.

## Most influential descendants
- K233858: TriSalus TriGuideTM Guiding Catheter (2023), 0 descendants of its own
- K162359: Surefire Guiding Catheter (2016), 0 descendants of its own

## Indications for use
The Surefire Guiding Catheter is intended to provide a pathway through which therapeutic devices are introduced. The Surefire Guiding Catheter is intended to be used in the peripheral vascular system.

Source page: https://510kreport.com/device/K140034
Methodology: https://510kreport.com/methodology