# K982559: Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Galt Medical Corp.
- Decided: Feb 1, 1999 after 193 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: 1 generation back to K920884 (1992). 1 ancestor in all.
25 later devices descend from it; 5 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K920884: Guidewires, Various Types, Acme-Monaco Corp. (1992) Summary page 1.
- (no number) Argon Medical guidewires: named in the summary without a submission number
- (no number) Cordis guidewires: named in the summary without a submission number
- (no number) Cook guidewires: named in the summary without a submission number

## Most influential descendants
- K042370: Torayguide Guidewire (2004), 13 descendants of its own
- K132623: Medtronic Confida Brecker Curve Guidewire (2013), 11 descendants of its own
- K150465: Medtronic Confida Brecker Guidewire (2015), 9 descendants of its own
- K181001: Medtronic Confida Brecker Guidewire (2018), 8 descendants of its own
- K021990: Galt Medical Guidewire (2002), 8 descendants of its own

## Recalls of this device
- Mar 27, 2025 · Class II · Z-1734-2025: Due to a potential open seal in the sterile barrier packaging.

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

Source page: https://510kreport.com/device/K982559
Methodology: https://510kreport.com/methodology