# K080863: Traxcess 0.014 Hydrophilic Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: MicroVention, Inc.
- Decided: Apr 17, 2008 after 20 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 K953533 (1995). 5 ancestors in all.
12 later devices descend from it; 2 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063695: Runthrough NS, Terumo Medical Corp. (2007) Summary page 1.
- K971254: Transend EX Platinum Guidewire, Boston Scientific Corp (1997) Summary page 1.
- K955801: Radifocus Glidewire GT with Gold Coil,Glidewire Gold, Terumo Medical Corp. (1996) Summary page 1.

## Most influential descendants
- K133725: Traxcess 14 Guidewire (2014), 9 descendants of its own
- K153053: Traxcess Pro 14 Guidewire (2015), 4 descendants of its own
- K161803: Traxcess .007 Mini Guidewire (2016), 2 descendants of its own
- K182337: HYBRID Guidewire (2018), 1 descendant of its own
- K093397: Traxcess 14EX Guidewire and Traxcess Docking Wire (2009), 1 descendant of its own

## Indications for use
The Traxcess 0.014" Hydrophilic Guidewire 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/K080863
Methodology: https://510kreport.com/methodology