# K133155: Hydrophilic Coated Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Lake Region Medical
- Decided: Apr 7, 2014 after 172 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 K000011 (2000). 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)
- K000011: Modified Hydrophilic Coated Guidewire, Lake Region Mfg., Inc. (2000)

## Most influential descendants
- K170915: TXM Hydrophilic Guidewire (2017), 0 descendants of its own

## Indications for use
To facilitate the placement of devices during diagnostic and interventional procedures.

Source page: https://510kreport.com/device/K133155
Methodology: https://510kreport.com/methodology