# K040140: IQ Guide Wire

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: Feb 12, 2004 after 21 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: 5 generations back to K913353 (1991). 22 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032183: IQ Hydrophilic Guide Wire, Boston Scientific Corp (2003) Summary page 1.

## Most influential descendants
- 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

## Recalls of this device
- May 30, 2006 · Not classified · Z-1213-06: Boston Scientific discovered through an internal inspection process that the PTFE (polytetrafluoroethylene) coating is not consistently adhering to the transition area of the distal end of the guide w

## Indications for use
The IQTM Guide Wires are intended to facilitate the placement of balloon dilatation catheters or other therapeutic devices during PTCA, PTA, or other intravascular interventional procedures. The IQTM Guide Wires are not intended for use in the cerebral vasculature.

Source page: https://510kreport.com/device/K040140
Methodology: https://510kreport.com/methodology