# K973945: Luge Guide Wire

- Pathway: 510(k) (Traditional)
- Applicant: Scimed Life Systems, Inc.
- Decided: Jan 12, 1998 after 88 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
No predicates in its family tree.
6 later devices descend from it; 2 cite it directly.
0 of 7 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) ChoICE Family of Guide Wires: named in the summary without a submission number
- (no number) Sceptor Family of Guide Wires: named in the summary without a submission number
- (no number) ChoICE PT Family of Guide Wires: named in the summary without a submission number

## Most influential descendants
- K032183: IQ Hydrophilic Guide Wire (2003), 4 descendants of its own
- K040140: IQ Guide Wire (2004), 3 descendants of its own
- K081021: Kinetix Guidewire, Plus Guidewire (2008), 1 descendant of its own
- K193194: CrossTorq 14 Guidewire (2019), 0 descendants of its own
- K052783: Modification to: IQ Guide Wire, Models 38950-XX. 38951-XX (2005), 0 descendants of its own

## Indications for use
The SCIMED Luge Guide Wire is intended to facilitate the placement and exchange of balloon dilatation catheters or other therapeutic devices during PTCA or other intravascular interventional procedures. The SCIMED Luge Guide Wire is not intended for use in the cerebral vasculature. The devices are provided sterile and intended for one procedure only.

Source page: https://510kreport.com/device/K973945
Methodology: https://510kreport.com/methodology