# K162359: Surefire Guiding Catheter

- Pathway: 510(k) (Special)
- Applicant: Surefire Medical, Inc.
- Decided: Sep 21, 2016 after 29 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: 4 generations back to K981198 (1998). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140034: Surefire Guiding Catheter, Surefire Medical, Inc. (2014) Summary page 4.

## 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/K162359
Methodology: https://510kreport.com/methodology