# K031864: Nitrex Nitinol Guidewire

- Pathway: 510(k) (Special)
- Applicant: Ev3 Corporation
- Decided: Jun 24, 2003 after 8 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: 2 generations back to K910280 (1991). 4 ancestors in all.
48 later devices descend from it; 3 cite it directly.
5 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910280: Ultra-Select Ptca Guidewire, Microvena Corp. (1991) Summary page 1.
- 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.

## Most influential descendants
- K062192: Ostial Pro Stent Positioning System (2007), 35 descendants of its own
- K083745: The IC-Pro System, Model Version 3.2 (2009), 30 descendants of its own
- K110256: The IC-Pro System (2011), 15 descendants of its own
- K100292: Caas Qva 3D, Caas Qca 3D (2010), 13 descendants of its own
- K091781: Guided Medical Positioning System (GMPS) (2009), 11 descendants 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/K031864
Methodology: https://510kreport.com/methodology