# K003483: Modified Hydrophilic Coated Guidewire (Stainless Steel Core)

- Pathway: 510(k) (Special)
- Applicant: Lake Region Mfg., Inc.
- Decided: Dec 6, 2000 after 27 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
No predicates in its family tree.
41 later devices descend from it; 1 cites it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K031842: Safe-Cross Radio Frequency Total Occlusion Crossing System (2003), 40 descendants of its own
- K040067: Clirpath Excimer Laser Catheter (2004), 36 descendants of its own
- K043465: 2.5 MM Turbo Clirpath Excimer Laser Catheter, Model 225-011 (2005), 25 descendants of its own
- K052296: Clirpath Turbo Excimer Laser Catheters (2005), 24 descendants of its own
- K052514: Clirpath Turbo Plus Excimer Laser Catheters, Models 314-151, 314-159, 317-152, 317-156, 320-006, 320-159, 323-001 (2005), 23 descendants of its own

Source page: https://510kreport.com/device/K003483
Methodology: https://510kreport.com/methodology