# K040825: Lake Region Hydrophilic Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Lake Region Mfg., Inc.
- Decided: May 17, 2004 after 48 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: 1 generation back to K003084 (2001). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003084: Concentric Hydrophilic Guidewire, Models 90011, 90012, Concentric Medical, Inc. (2001) Summary page 2.

## Most influential descendants
- K081775: The Medcomp .010 Vascular Guidewires (2009), 0 descendants of its own

## Indications for use
The Lake Region Hydrophilic Guidewire is indicated for general intravascular use to aid in the selective placement of catheters in the coronary, peripheral, visceral and cerebral vasculature.

Source page: https://510kreport.com/device/K040825
Methodology: https://510kreport.com/methodology