# K992237: Medtronic GT2 Fusion Guide Wires

- Pathway: 510(k) (Special)
- Applicant: Medtronic Vascular
- Decided: Sep 9, 1999 after 69 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 K890505 (1989). 4 ancestors in all.
No later device cites it as a predicate yet.
1 of 5 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983927: GT1 Floppy, GT1 HI-Per Flex, GT1 Light Support, Arterial Vascular Engineering, Inc. (1999) Summary page 1.
- K974713: Bard Hydrophillic Coated Guide Wire, C.R. Bard, Inc. (1998) Summary page 1.
- K961271: Usci Commander Series Guide Wires, C.R. Bard, Inc. (1996) Summary page 1.
- (no number) AVE GT1 Guide Wire: named in the summary without a submission number

## Indications for use
GT2 Fusion Guide Wires are steerable guide wires that are used for the introduction and placement of diagnostic or interventional devices in the coronary and peripheral vasculature and may be used to reach and cross a target lesion. The GT2 Fusion Guide Wires are not intended for use in the cerebral vasculature. GT2 Fusion steerable exchange wires are used to facilitate the substitution of one diagnostic or interventional device for another

Source page: https://510kreport.com/device/K992237
Methodology: https://510kreport.com/methodology