# K011968: Streerable Ptca Guidewire

- Pathway: 510(k) (Special)
- Applicant: Lake Region Mfg., Inc.
- Decided: Jul 25, 2001 after 30 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K970376 (1997). 1 ancestor in all.
70 later devices descend from it; 4 cite it directly.
5 of 72 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.

## Most influential descendants
- K022813: Steerable Guidewire (2003), 49 descendants of its own
- 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

## Recalls of this device
- May 12, 2009 · Not classified · Z-1486-2009: Product packaged incorrectly. One batch/lot of wires, that should contain radiopaque marker bands, is missing the marker bands; and a second batch/lot of wires, which should not contain radiopaque mar
- May 12, 2009 · Not classified · Z-1487-2009: Product packaged incorrectly. One batch/lot of wires, that should contain radiopaque marker bands, is missing the marker bands; and a second batch/lot of wires, which should not contain radiopaque mar

## 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/K011968
Methodology: https://510kreport.com/methodology