# K140695: Cougar Guidewire, Zinger Guidwire, Thunder Guidewire, Provia Guidewire, Intuition Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic, Inc.
- Decided: Jun 12, 2014 after 85 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: 3 generations back to K970466 (1997). 7 ancestors in all.
No later device cites it as a predicate yet.
5 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091582: GTX Guidewire, Models TBD-GTX 1, 3,6,9,12, 15, Medtronic Vascular (2009) Summary page 1.
- K100470: GTX 12 Gidewire, Medtronic, Inc. (2010) Summary page 1.
- K970466: Radius Ptca Guidewire, Radius Medical Technologies, Inc. (1997) Summary page 1.
- K983927: GT1 Floppy, GT1 HI-Per Flex, GT1 Light Support, Arterial Vascular Engineering, Inc. (1999) Summary page 1.
- K032899: Radius Cougar Wire, Radius Medical Technologies, Inc. (2003) Summary page 1.

## Indications for use
Medtronic Pro ViaTm and IntuitionTM Guidewires: Medtronic [Pro ViaTM and JntuitionTM] GTX 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. Medtronic guide wires are not intended for use in the cerebral vasculature. Medtronic steerable exchange wires are used to facilitate the substitution of one diagnostic or interventional device for another. ThunderM Guidewires: Medtronic [ThunderM] PTCA guidewire is indicated to facilitate the placement of balloon dilatation catheters during PTCA and/or PTA. ZingeTm Guidewires: Medtronic [ZingerTM] 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. [ZingerTM] guide wires are not intended for use in the cerebral vasculature. Medtronic steerable exchange wires are used to facilitate the substitution of one diagnostic or interventional device for another. CougarTrmCuidewires: Medtronic CougarTM wire is intended for placement of balloon dilatation catheters during PTCA and/or PTA.

Source page: https://510kreport.com/device/K140695
Methodology: https://510kreport.com/methodology