# K140485: Mandrel Guidewire

- Pathway: 510(k) (Special)
- Applicant: Lake Region Medical
- Decided: Mar 27, 2014 after 29 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: 2 generations back to K770977 (1977). 4 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 7 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 1.
- K033758: Hydrophilic Guidewire, Lake Region Mfg., Inc. (2003) Summary page 1.
- K080144: Mandrel Guidewires or M-Wires, Lake Region Mfg., Inc. (2008) Summary page 1.

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

## Indications for use
Mandrel guidewires are intended 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/K140485
Methodology: https://510kreport.com/methodology