# K043457: Modification to Endovascular Guide Wire

- Pathway: 510(k) (Special)
- Applicant: Stereotaxis, Inc.
- Decided: Feb 28, 2005 after 75 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.
1 later device descends from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have 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
- K080637: Powerasset Radiofrequency Guidwire, Model Various (2008), 0 descendants of its own

## Indications for use
Stereotaxis AssertTM 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.

Source page: https://510kreport.com/device/K043457
Methodology: https://510kreport.com/methodology