# K171997: Mandril Wire Guide

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Mar 30, 2018 after 270 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K770977 (1977). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143135: Spring Coil Guidewire, Neometrics, Inc. (2015) Summary page 4.

## Most influential descendants
- K181353: Lunderquist® Fixed Core Wire Guide (2019), 0 descendants of its own

## Recalls of this device
- Aug 16, 2022 · Class II · Z-1843-2022: Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
- Aug 16, 2022 · Class II · Z-1829-2022: Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
- Aug 16, 2022 · Class II · Z-1830-2022: Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.

## Indications for use
To facilitate the placement of devices during diagnostic or interventional procedures.

Source page: https://510kreport.com/device/K171997
Methodology: https://510kreport.com/methodology