# K983771: Strategy Coronary Wire Guide

- Pathway: 510(k) (Special)
- Applicant: Cook, Inc.
- Decided: Nov 12, 1998 after 17 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Roadrunner™ RLTF Guide Wire: named in the summary without a submission number
- (no number) ACS Hi-Torque Cross-It™ Guide Wire with Hydrocoat™ Coating: named in the summary without a submission number

## Indications for use
Intended for use in facilitating delivery of a PTCA balloon catheter or other cardiovascular device into the cardiovascular system.

Source page: https://510kreport.com/device/K983771
Methodology: https://510kreport.com/methodology