# K040345: Modification to Nitrex Nitinol Guidewire

- Pathway: 510(k) (Special)
- Applicant: Ev3, Inc.
- Decided: Mar 2, 2004 after 19 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 K970376 (1997). 8 ancestors in all.
11 later devices descend from it; 2 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K893626: Flexmedics Guidewire, Flexmedics (1989) Summary page 1.
- K943390: Flexfinder Guidewire, Flexmedics (1995) Summary page 1.
- K024021: Nitrex Nitinol Guidewire, Ev3 Corporation (2003) Summary page 1.
- K031864: Nitrex Nitinol Guidewire, Ev3 Corporation (2003) Summary page 1.
- K022813: Steerable Guidewire, Lake Region Mfg., Inc. (2003) Summary page 1.

## Most influential descendants
- K050756: Skipper and Skipper Race Guidewire (2005), 10 descendants of its own
- K060551: Brivant Guidewire (2006), 9 descendants of its own
- K083094: Streamer Polymer Guidewire (2009), 3 descendants of its own
- K103377: Charter Guidewire Model 45-281, 45-282, 45-283 (2011), 2 descendants of its own
- K160643: ENROUTE 0.014 Guidewire (2016), 1 descendant of its own

## Indications for use
The 0.035" and 0.025" Guidewire is indicated for use in the peripheral vasculature. The 0.014", 0.016", and 0.018" guidewires are indicated for use in the peripheral and coronary vasculature.

Source page: https://510kreport.com/device/K040345
Methodology: https://510kreport.com/methodology