# K200547: Traxcess 14 SELECT Guidewire

- Pathway: 510(k) (Special)
- Applicant: MicroVention, Inc.
- Decided: Apr 16, 2020 after 44 days
- Product code: MOF (Guide, Wire, Catheter, Neurovasculature)
- 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: 6 generations back to K953533 (1995). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 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.

## Indications for use
The Traxcess™ 14 SELECT 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 intended for use in coronary arteries.

Source page: https://510kreport.com/device/K200547
Methodology: https://510kreport.com/methodology