# K983927: GT1 Floppy, GT1 HI-Per Flex, GT1 Light Support

- Pathway: 510(k) (Traditional)
- Applicant: Arterial Vascular Engineering, Inc.
- Decided: Mar 11, 1999 after 126 days
- Product code: DQT (Occluder, Catheter Tip)
- Device class: 2
- Regulation: 21 CFR 870.1370
- Recalls of this device: 2 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 4 cite it directly.
2 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Commander Floppy: named in the summary without a submission number
- (no number) Commander Hi-Per Flex: named in the summary without a submission number
- (no number) Commander Light Support: named in the summary without a submission number

## Most influential descendants
- K063210: Attain Hybrid Guide Wires, Model GWR419378, GWR419388, GWR419478, GWR419488 (2007), 1 descendant of its own
- K143316: Attain Hybrid Guide Wire (2015), 0 descendants of its own
- K140695: Cougar Guidewire, Zinger Guidwire, Thunder Guidewire, Provia Guidewire, Intuition Guidewire (2014), 0 descendants of its own
- K101729: Neowire Pta/Ptca Guidewire (2010), 0 descendants of its own
- K992237: Medtronic GT2 Fusion Guide Wires (1999), 0 descendants of its own

## Recalls of this device
- Oct 21, 2013 · Class I · Z-0268-2014: Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire.
- Oct 21, 2013 · Class I · Z-0262-2014: Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire.

## Indications for use
AVE 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. AVE guide wires are not intended for use in the cerebral vasculature. AVE steerable exchange wires are used to facilitate the substitution of one diagnostic or interventional device for another.

Source page: https://510kreport.com/device/K983927
Methodology: https://510kreport.com/methodology