# K042370: Torayguide Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Toray Industries (America), Inc.
- Decided: Dec 17, 2004 after 108 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 K920884 (1992). 2 ancestors in all.
13 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982559: Guidewire, Galt Medical Corp. (1999) Summary page 1.

## Most influential descendants
- K132623: Medtronic Confida Brecker Curve Guidewire (2013), 11 descendants of its own
- K150465: Medtronic Confida Brecker Guidewire (2015), 9 descendants of its own
- K181001: Medtronic Confida Brecker Guidewire (2018), 8 descendants of its own
- K192454: Wattson Temporary Pacing Guidewire (2020), 6 descendants of its own
- K213854: SavvyWire (2022), 4 descendants of its own

## Indications for use
The TORAYGuide guidewire is intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the heart and peripheral vasculature. The device is not intended for use in the coronary arteries.

Source page: https://510kreport.com/device/K042370
Methodology: https://510kreport.com/methodology