# K130766: Roadrunner Uniglide Hydrophilic Wire Guide

- Pathway: 510(k) (Special)
- Applicant: Cook, Inc.
- Decided: Jul 17, 2013 after 119 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K920891 (1992). 3 ancestors in all.
No later device cites it as a predicate yet.
2 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110009: Roadrunner Uniglide Hydrophilic Wire Guide, Cook, Inc. (2011) Summary page 1.

## Recalls of this device
- Jun 24, 2016 · Class I · Z-2537-2016: Potential coating contamination with glass particles.

## Indications for use
For use in facilitating delivery of percutaneous catheters into the peripheral vasculature.

Source page: https://510kreport.com/device/K130766
Methodology: https://510kreport.com/methodology