# K251596: Lunderquist Extra Stiff Wire Guide

- Pathway: 510(k) (Special)
- Applicant: William Cook Europe Aps
- Decided: Nov 9, 2025 after 166 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K061670 (2007). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220137: Lunderquist Extra Stiff Wire Guide, William Cook Europe Aps (2022) Summary page 5.

## Indications for use
The Lunderquist Extra Stiff Wire Guides are intended to facilitate catheterization and/or placement of devices during vascular interventional procedures. The Lunderquist Extra Stiff Wire Guides are intended for use in the aorta, including its access vessels and major adjacent vessels. The Lunderquist Extra Stiff Wire Guides are auxiliary devices and hence not primary interventional devices themselves. Instead, they are intended to facilitate vascular access and/or delivery of over-the-wire medical devices during endovascular procedures, including TEVAR/EVAR procedures. The Lunderquist Extra Stiff Wire Guides are both long and stiff; features that make them suitable for facilitating endovascular procedures that involve placement of large devices e.g., stent grafts in the aorta. The wire guides are not intended for coronary or neurovascular use.

Source page: https://510kreport.com/device/K251596
Methodology: https://510kreport.com/methodology