# K110009: Roadrunner Uniglide Hydrophilic Wire Guide

- Pathway: 510(k) (Special)
- Applicant: Cook, Inc.
- Decided: Feb 2, 2011 after 30 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- Recalls of this device: 10 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K920891 (1992). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
2 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091385: Approach Hydro ST Wire Guide, Model HMW, Cook, Inc. (2009) Summary page 1.
- K920891: Roadrunner (TM) Wire Guide, Modification, Cook, Inc. (1992) Summary page 1.

## Most influential descendants
- K130766: Roadrunner Uniglide Hydrophilic Wire Guide (2013), 0 descendants of its own
- K123707: Alight 16 Superselective Microwire Guide (2013), 0 descendants of its own

## Recalls of this device
- Jul 19, 2022 · Class II · Z-1710-2022: Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
- Jul 19, 2022 · Class II · Z-1717-2022: Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
- Jul 19, 2022 · Class II · Z-1715-2022: Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
- Jul 19, 2022 · Class II · Z-1713-2022: Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
- Jul 19, 2022 · Class II · Z-1712-2022: Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
- Jul 19, 2022 · Class II · Z-1711-2022: Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
- Jul 19, 2022 · Class II · Z-1718-2022: Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
- Jul 19, 2022 · Class II · Z-1714-2022: Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
- Jul 19, 2022 · Class II · Z-1716-2022: Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
- 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/K110009
Methodology: https://510kreport.com/methodology