# K181353: Lunderquist® Fixed Core Wire Guide

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Feb 15, 2019 after 269 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 K770977 (1977). 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)
- K171997: Mandril Wire Guide, Cook Incorporated (2018) Summary page 4.

## Indications for use
The Lunderquist Fixed Core Wire Guides are intended to facilitate placement of devices used during diagnostic and interventional procedures.

Source page: https://510kreport.com/device/K181353
Methodology: https://510kreport.com/methodology