# K080144: Mandrel Guidewires or M-Wires

- Pathway: 510(k) (Special)
- Applicant: Lake Region Mfg., Inc.
- Decided: Feb 26, 2008 after 35 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: 1 generation back to K011084 (2001). 1 ancestor in all.
3 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011084: Mandrel Guidewire Assembly, Lake Region Mfg., Inc. (2001) Summary page 2.

## Most influential descendants
- K140485: Mandrel Guidewire (2014), 2 descendants of its own
- K142393: Predicate Iii Guidewire (2014), 1 descendant of its own
- K241784: Arrow® Nitinol Wire (2024), 0 descendants of its own

## Indications for use
For use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature.

Source page: https://510kreport.com/device/K080144
Methodology: https://510kreport.com/methodology