# K994358: Atw Marker Wire Steerable Guidewire

- Pathway: 510(k) (Special)
- Applicant: Cordis Corp.
- Decided: Jan 13, 2000 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.
46 later devices descend from it; 3 cite it directly.
5 of 47 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 its predicate without a number.
- (no number) ST Steerable Guidewire: named in the summary without a submission number
- (no number) Wizdom Marker Wire: named in the summary without a submission number
- (no number) Stabilizer Marker Wire Steerable Guidewires: named in the summary without a submission number

## Most influential descendants
- 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
- K091781: Guided Medical Positioning System (GMPS) (2009), 11 descendants of its own

## Indications for use
The Cordis guidewires are intended for use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature. In addition, the Cordis ATW Marker Wire Steerable Guidewires are intended to facilitate the alignment of interventional devices and function as a measurement tool.

Source page: https://510kreport.com/device/K994358
Methodology: https://510kreport.com/methodology