# K161803: Traxcess .007 Mini Guidewire

- Pathway: 510(k) (Special)
- Applicant: MicroVention, Inc.
- Decided: Sep 30, 2016 after 92 days
- Product code: MOF (Guide, Wire, Catheter, Neurovasculature)
- Device class: 2
- Regulation: 21 CFR 870.1330
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K953533 (1995). 8 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153053: Traxcess Pro 14 Guidewire, MicroVention, Inc. (2015) Summary page 4.

## Most influential descendants
- K201487: Traxcess 7 Mini Guidewire (2020), 0 descendants of its own
- K163154: Traxcess 7 Mini XSoft Guidewire (2016), 0 descendants of its own

## Recalls of this device
- Aug 7, 2017 · Class II · Z-3103-2017: There is a potential for the hydrophilic coating on the guidewire to delaminate from the guidewire.

## Indications for use
Traxcess .007" Mini Guidewire is indicated for general intravascular use, including the neuro and peripheral vasculature. The guidewire can be steered to facilitate the selective placement of diagnostic or therapeutic catheters. This device is not indicated for use in coronary arteries.

Source page: https://510kreport.com/device/K161803
Methodology: https://510kreport.com/methodology