# K093397: Traxcess 14EX Guidewire and Traxcess Docking Wire

- Pathway: 510(k) (Special)
- Applicant: MicroVention, Inc.
- Decided: Dec 17, 2009 after 48 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: 4 generations back to K953533 (1995). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080863: Traxcess 0.014 Hydrophilic Guidewire, MicroVention, Inc. (2008) Summary page 1.
- K080563: Runthrough NS Extension Wire, Terumo Medical Corp. (2008) Summary page 1.

## Most influential descendants
- K191687: pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire (2019), 0 descendants of its own

## Indications for use
The Traxcess Guidewire and Traxcess Docking Wire is intended for general intravascular use, including the neuro and peripheral vasculature. The wire can be steered to facilitate the selective placement of diagnostic or therapeutic catheters. This device is not intended for use in coronary arteries.

Source page: https://510kreport.com/device/K093397
Methodology: https://510kreport.com/methodology