Guidewires
Nitrex
by EV3, Inc
A long, thin wire intended to be percutaneously placed into the peripheral vasculature (not heart or central nervous system) to function as a guide for the introduction of devices (e.g., catheters). It is made of metal (e.g., stainless steel, Nitinol), with or without coating, and is available in a variety of distal tip designs. It is intended to be used for percutaneous angiography, angioplasty, rotational atherectomy and thrombectomy, drainage, and other diagnostic and interventional procedures. It may include devices used to facilitate manipulation (e.g., torque device). This is a single-use device.
Nitrex models and sizes
From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.
| Model / catalog no. | Size | MRI | Status |
|---|---|---|---|
| N140801 | Guidewire Length 80.0 cm; Guidewire Diameter 0.36 mm | Not stated | Available |
| N141802 | Guidewire Diameter 0.36 mm; Guidewire Length 180.0 cm | Not stated | Available |
| N143001 | Guidewire Length 300.0 cm; Guidewire Diameter 0.36 mm | Not stated | Available |
| N180601 | Guidewire Diameter 0.46 mm; Guidewire Length 60.0 cm | Not stated | Available |
| N180603 | Guidewire Length 60.0 cm; Guidewire Diameter 0.46 mm | Not stated | Available |
| N180801 | Guidewire Diameter 0.46 mm; Guidewire Length 80.0 cm | Not stated | Available |
| N180802 | Guidewire Length 80.0 cm; Guidewire Diameter 0.46 mm | Not stated | Available |
| N181804 | Guidewire Diameter 0.46 mm; Guidewire Length 180.0 cm | Not stated | Available |
| N181805 | Guidewire Diameter 0.46 mm; Guidewire Length 180.0 cm | Not stated | Available |
| N181806 | Guidewire Diameter 0.46 mm; Guidewire Length 180.0 cm | Not stated | Available |
| N183001 | Guidewire Length 300.0 cm; Guidewire Diameter 0.46 mm | Not stated | Available |
| N183002 | Guidewire Diameter 0.46 mm; Guidewire Length 300.0 cm | Not stated | Available |
| N251801 | Guidewire Diameter 0.64 mm; Guidewire Length 180.0 cm | Not stated | Available |
| N251802 | Guidewire Length 180.0 cm; Guidewire Diameter 0.64 mm | Not stated | Available |
| N252601 | Guidewire Length 260.0 cm; Guidewire Diameter 0.64 mm | Not stated | Available |
| N350801 | Guidewire Length 80.0 cm; Guidewire Diameter 0.89 mm | Not stated | Available |
| N351451 | Guidewire Diameter 0.89 mm; Guidewire Length 145.0 cm | Not stated | Available |
| N351452 | Guidewire Diameter 0.89 mm; Guidewire Length 145.0 cm | Not stated | Available |
| N351453 | Guidewire Length 145.0 cm; Guidewire Diameter 0.89 mm | Not stated | Available |
| N351454 | Guidewire Diameter 0.89 mm; Guidewire Length 145.0 cm | Not stated | Available |
| N351455 | Guidewire Length 145.0 cm; Guidewire Diameter 0.89 mm | Not stated | Available |
| N351803 | Guidewire Length 180.0 cm; Guidewire Diameter 0.89 mm | Not stated | Available |
| N351804 | Guidewire Length 180.0 cm; Guidewire Diameter 0.89 mm | Not stated | Available |
| N351805 | Guidewire Diameter 0.89 mm; Guidewire Length 180.0 cm | Not stated | Available |
| N352601 | Guidewire Length 260.0 cm; Guidewire Diameter 0.89 mm | Not stated | Available |
| N352602 | Guidewire Length 260.0 cm; Guidewire Diameter 0.89 mm | Not stated | Available |
| N352603 | Guidewire Diameter 0.89 mm; Guidewire Length 260.0 cm | Not stated | Available |
| N352604 | Guidewire Length 260.0 cm; Guidewire Diameter 0.89 mm | Not stated | Available |
| N353001 | Guidewire Diameter 0.89 mm; Guidewire Length 300.0 cm | Not stated | Available |
| N354001 | Guidewire Diameter 0.89 mm; Guidewire Length 400.0 cm | Not stated | Available |
| N354002 | Guidewire Diameter 0.89 mm; Guidewire Length 400.0 cm | Not stated | Available |
FDA clearances
- 510(k) K040345 March 2004
Procedures that use guidewires
Frequently asked questions
What is Nitrex used for?
A long, thin wire intended to be percutaneously placed into the peripheral vasculature (not heart or central nervous system) to function as a guide for the introduction of devices (e.g., catheters). It is made of metal (e.g., stainless steel, Nitinol), with or without coating, and is available in a variety of distal tip designs. It is intended to be used for percutaneous angiography, angioplasty, rotational atherectomy and thrombectomy, drainage, and other diagnostic and interventional procedures. It may include devices used to facilitate manipulation (e.g., torque device). This is a single-use device.
Who makes Nitrex?
Nitrex is made by EV3, Inc. It is listed under guidewires in our device library.
What sizes does Nitrex come in?
Sizes listed for Nitrex: Guidewire Diameter: 0.36–0.89 mm; Guidewire Length: 60–400 cm. Confirm availability with the manufacturer's instructions for use.
Is Nitrex MRI safe?
The FDA device database entry for Nitrex does not state its MRI safety status. Check the labeling before MRI.
Is Nitrex FDA cleared?
Nitrex is covered by FDA submission K040345.
How do I contact a EV3, Inc sales representative?
EV3, Inc has not listed representatives on LA Vascular yet. Visit the EV3, Inc company page for contact details.
Models, sizes and MRI status come from the FDA Global Unique Device Identification Database (GUDID); descriptions marked "provided by the manufacturer" are reviewed before publishing. Not an endorsement; follow the manufacturer's instructions for use.