Guidewires
Traxcess
A long, thin, sterile wire intended to be percutaneously placed into the cardiac vasculature (ventricles or coronary vessels) to function as a guide for the introduction, positioning, and/or operation of a device (e.g., catheter, pacing lead); it may also be used in the peripheral vasculature. It may be made of metal (e.g., stainless steel, Nitinol), or polymer and/or glass materials to provide MRI-compatibility, with or without coating, and is available in a variety of distal tip designs. It is used for various diagnostic and interventional procedures, and may include devices used to facilitate manipulation (e.g., torque device). This is a single-use device.
Traxcess 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 |
|---|---|---|---|
| GW0721006M-AL | — | Not stated | Available |
| GW1420040SK | — | Not stated | Available |
| GW1420040SK-AL | — | Not stated | Available |
FDA clearances
- 510(k) K201487 July 2020
- 510(k) K200547 April 2020
Procedures that use guidewires
Frequently asked questions
What is Traxcess used for?
A long, thin, sterile wire intended to be percutaneously placed into the cardiac vasculature (ventricles or coronary vessels) to function as a guide for the introduction, positioning, and/or operation of a device (e.g., catheter, pacing lead); it may also be used in the peripheral vasculature. It may be made of metal (e.g., stainless steel, Nitinol), or polymer and/or glass materials to provide MRI-compatibility, with or without coating, and is available in a variety of distal tip designs. It is used for various diagnostic and interventional procedures, and may include devices used to facilitate manipulation (e.g., torque device). This is a single-use device.
Who makes Traxcess?
Traxcess is made by Microvention, Inc.. It is listed under guidewires in our device library.
What sizes does Traxcess come in?
The FDA device database does not list sizes for Traxcess. Check the instructions for use or ask a Microvention, Inc. representative.
Is Traxcess MRI safe?
The FDA device database entry for Traxcess does not state its MRI safety status. Check the labeling before MRI.
Is Traxcess FDA cleared?
Traxcess is covered by FDA submissions K200547, K201487.
How do I contact a Microvention, Inc. sales representative?
Microvention, Inc. has not listed representatives on LA Vascular yet. Visit the Microvention, 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.