# K162384: TrailBlazer Angled Support Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Vascular, Inc.(Formerly Ev3 Inc.)
- Decided: Sep 22, 2016 after 28 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: 7 generations back to K935425 (1994). 18 ancestors in all.
No later device cites it as a predicate yet.
1 of 19 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092299: Trailblazer Support Catheter, Ev3, Inc. (2009) Summary page 4.
- K122796: Cxi Support Catheter, Cook, Inc. (2012) Summary page 4.

## Indications for use
The TrailBlazer™ angled support catheters are percutaneous, single lumen catheters designed for use in the peripheral vascular system. The TrailBlazer™ angled support catheters are intended to guide and support a guide wire during access of the vasculature, to allow for guide wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

Source page: https://510kreport.com/device/K162384
Methodology: https://510kreport.com/methodology