# K021990: Galt Medical Guidewire

- Pathway: 510(k) (Special)
- Applicant: Galt Medical Corp.
- Decided: Jul 18, 2002 after 30 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: 2 generations back to K920884 (1992). 2 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 11 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.

## Most influential descendants
- K151234: R350 guidewire (2015), 5 descendants of its own
- K161702: Endura guidewire (2016), 4 descendants of its own
- K163444: Spectre guidewire (2017), 3 descendants of its own
- K173532: Raider Guidewire (2017), 1 descendant of its own
- K031916: Galt Medical Guidewire (2003), 1 descendant of its own

## Recalls of this device
- Jun 26, 2026 · Class II · Z-2917-2026: Black depth markings may detach from the outer sheath of the coaxial dilator introducer component of transcarotid-peripheral access kits.

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

Source page: https://510kreport.com/device/K021990
Methodology: https://510kreport.com/methodology