# K092299: Trailblazer Support Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Ev3, Inc.
- Decided: Aug 7, 2009 after 9 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K935425 (1994). 12 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 15 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072750: Spectranetics Quick-Cross SUPPORT2 Catheters, Models 518-065 and 518-066, Spectranetics Corp. (2007) Summary page 1.
- K082337: Minnie Support Catheter, Vascular Solutions, Inc. (2009) Summary page 1.

## Most influential descendants
- K170914: TXM Support Catheter (2017), 0 descendants of its own
- K162384: TrailBlazer Angled Support Catheter (2016), 0 descendants of its own

## Recalls of this device
- Nov 6, 2009 · Not classified · Z-0497-2010: Catheter may crack near the radiopaque marker band at the distal end of the device during use. Cracking of the catheter shaft in this location can result in material separation, and potential emboliza

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

Source page: https://510kreport.com/device/K092299
Methodology: https://510kreport.com/methodology