# K970376: Ptca Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Lake Region Mfg., Inc.
- Decided: Jun 6, 1997 after 123 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.
87 later devices descend from it; 7 cite it directly.
5 of 88 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K011968: Streerable Ptca Guidewire (2001), 70 descendants of its own
- 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

## Indications for use
Lake Region’s steerable quidewires are 1intended for wuse in angiographic procedures to introduce and position catheters and interventional devices within the <coronary and peripheral vasculature. The attachment of the guidewire extension to the Lake Region Steerable guidewire creates a gquidewire that can be used to exchange a catheter without removing the guidewire from the vessel. When the exchange is complete, the guidewire extension can be detached and the original guidewire can again be used in a conventional manner.

Source page: https://510kreport.com/device/K970376
Methodology: https://510kreport.com/methodology