# K022813: Steerable Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Lake Region Mfg., Inc.
- Decided: Feb 14, 2003 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: 2 generations back to K970376 (1997). 2 ancestors in all.
49 later devices descend from it; 2 cite it directly.
5 of 52 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)

## Most influential descendants
- K042338: Coronary Peripheral and Renal Steerable Guidewire (2004), 36 descendants of its own
- K062192: Ostial Pro Stent Positioning System (2007), 35 descendants of its own
- K083745: The IC-Pro System, Model Version 3.2 (2009), 30 descendants of its own
- K110256: The IC-Pro System (2011), 15 descendants of its own
- K100292: Caas Qva 3D, Caas Qca 3D (2010), 13 descendants of its own

## Indications for use
Lake Region's steerable guidewires are intended for use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature, including the renal vasculature. The steerability feature allows the guidewire to be torqued to facilitate navigation through the vasculature.

Source page: https://510kreport.com/device/K022813
Methodology: https://510kreport.com/methodology