# K041624: Ptca Steerable Hydrophilic Guidewire

- Pathway: 510(k) (Special)
- Applicant: Lake Region Mfg., Inc.
- Decided: Jul 16, 2004 after 30 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 K970376 (1997). 2 ancestors in all.
4 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)
- K970376: Ptca Guidewire, Lake Region Mfg., Inc. (1997) Summary page 2.
- K011968: Streerable Ptca Guidewire, Lake Region Mfg., Inc. (2001) Summary page 2.

## Most influential descendants
- K052347: Titan Steerable (Ptca) Guidewire (2006), 2 descendants of its own
- K060454: Titan Guidewire (2006), 1 descendant of its own
- K082922: Freeway and Railrunner Guidewires (2008), 0 descendants of its own
- K073655: Pegasus Steerable (Ptca) Guidewire (2008), 0 descendants of its own

## 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/K041624
Methodology: https://510kreport.com/methodology