# K042854: Stereotaxis Endovascular Guide Wire

- Pathway: 510(k) (Special)
- Applicant: Stereotaxis, Inc.
- Decided: Feb 8, 2005 after 116 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
Longest line of descent: 3 generations back to K941895 (1994). 15 ancestors in all.
6 later devices descend from it; 4 cite it directly.
1 of 22 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021363: Endovascular Guide Wire, Stereotaxis, Inc. (2002) Summary page 2.

## Most influential descendants
- K052347: Titan Steerable (Ptca) Guidewire (2006), 2 descendants of its own
- K060454: Titan Guidewire (2006), 1 descendant of its own
- K080637: Powerasset Radiofrequency Guidwire, Model Various (2008), 0 descendants of its own
- K080364: Findrwirz Guide Wire System (2008), 0 descendants of its own
- K073655: Pegasus Steerable (Ptca) Guidewire (2008), 0 descendants of its own

## Indications for use
Stereotaxis Cronus® Guide Wires are intended to introduce and position over-the-wire catheters and other over-the-wire therapeutic devices within the coronary and peripheral vasculature during PTCA or other intravascular interventional procedures. Contraindications: This guide wire is not intended for use without the Stereotaxis Magnetic Navigation System. The device is not intended for use in the cerebral vasculature. Rotational atherectomy devices, and any ferromagnetic interventional devices, are contraindicated for use with Stereotaxis Cronus® Guide Wires.

Source page: https://510kreport.com/device/K042854
Methodology: https://510kreport.com/methodology