# K082922: Freeway and Railrunner Guidewires

- Pathway: 510(k) (Special)
- Applicant: Lake Region Mfg., Inc.
- Decided: Dec 9, 2008 after 69 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: 6 generations back to K890505 (1989). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970376: Ptca Guidewire, Lake Region Mfg., Inc. (1997) Summary page 2.
- K041624: Ptca Steerable Hydrophilic Guidewire, Lake Region Mfg., Inc. (2004) Summary page 2.
- K041531: Asahi Ptca Guide Wire Confianza Pro, Asahi Intecc Co., Ltd. (2004) Summary page 2.

## Indications for use
For use in Angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature.

Source page: https://510kreport.com/device/K082922
Methodology: https://510kreport.com/methodology