# K021363: Endovascular Guide Wire

- Pathway: 510(k) (Traditional)
- Applicant: Stereotaxis, Inc.
- Decided: Nov 27, 2002 after 211 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K941895 (1994). 14 ancestors in all.
8 later devices descend from it; 2 cite it directly.
1 of 23 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970244: Scimed Choice Family of Ptca Guide Wires, Scimed Life Systems, Inc. (1997) Summary page 2.
- K971815: Asc Balance Middleweight Guide Wire, Guidant Corp. (1997) Summary page 2.

## Most influential descendants
- K042854: Stereotaxis Endovascular Guide Wire (2005), 6 descendants of its own
- K052347: Titan Steerable (Ptca) Guidewire (2006), 2 descendants of its own
- K060454: Titan Guidewire (2006), 1 descendant of its own
- K043457: Modification to Endovascular Guide Wire (2005), 1 descendant of its own
- K080637: Powerasset Radiofrequency Guidwire, Model Various (2008), 0 descendants of its own

## Recalls of this device
- Jan 27, 2004 · Not classified · Z-0594-04: The magnet at the end of the guidewire could break off.
- Jan 27, 2004 · Not classified · Z-0592-04: The magnet at the end of the guidewire could break off.
- Jan 27, 2004 · Not classified · Z-0593-04: The magnet at the end of the guidewire could break off.
- Jan 27, 2004 · Not classified · Z-0590-04: The magnet at the end of the guidewire could break off.
- Jan 27, 2004 · Not classified · Z-0591-04: The magnet at the end of the guidewire could break off.
- Jan 27, 2004 · Not classified · Z-0595-04: The magnet at the end of the guidewire could break off.

## Indications for use
The Stereotaxis Endovascular Guide Wire is 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 the Stereotaxis Endovascular Guide Wire.

Source page: https://510kreport.com/device/K021363
Methodology: https://510kreport.com/methodology