# K142393: Predicate Iii Guidewire

- Pathway: 510(k) (Special)
- Applicant: Lake Region Medical
- Decided: Nov 25, 2014 after 90 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). 5 ancestors in all.
1 later device descends 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)
- K140485: Mandrel Guidewire, Lake Region Medical (2014) Summary page 4.

## Most influential descendants
- K241784: Arrow® Nitinol Wire (2024), 0 descendants of its own

## Indications for use
PREDICATE™ III GUIDEWIRE 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/K142393
Methodology: https://510kreport.com/methodology