# K031916: Galt Medical Guidewire

- Pathway: 510(k) (Special)
- Applicant: Galt Medical Corp.
- Decided: Jul 17, 2003 after 27 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K920884 (1992). 3 ancestors in all.
1 later device descends 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)
- K982559: Guidewire, Galt Medical Corp. (1999) Summary page 1.
- K021990: Galt Medical Guidewire, Galt Medical Corp. (2002) Summary page 1.

## Most influential descendants
- K033542: Easy Pass Hydrophilic Coated Vascular Guidewire (2003), 0 descendants of its own

## Recalls of this device
- Apr 11, 2008 · Not classified · Z-1909-2008: kit contains incorrect component

## Indications for use
These guidewires are intended for use in percutaneous procedures to introduce and position catheters, pacing leads and other interventional devices within the coronary and peripheral vasculature.

Source page: https://510kreport.com/device/K031916
Methodology: https://510kreport.com/methodology