# K081337: Approach Cto Wire Guide

- Pathway: 510(k) (Special)
- Applicant: Cook Incorporated
- Decided: Aug 8, 2008 after 87 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K101729: Neowire Pta/Ptca Guidewire (2010), 0 descendants of its own

## Indications for use
Indicated for use in facilitating delivery of percutaneous catheters into the cardiovascular system.

Source page: https://510kreport.com/device/K081337
Methodology: https://510kreport.com/methodology