Guidewires
X-pedion
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.
X-pedion 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 |
|---|---|---|---|
| 103-0605-200 | — | Not stated | Available |
| 103-0605-200 | — | Not stated | Available |
| 103-0605-200 | Length 200 cm | Not stated | Available |
| 203-0602-200 | Length 200 cm | Not stated | Available |
FDA clearances
- 510(k) K201690 July 2020
- 510(k) K193548 January 2020
- 510(k) K124007 March 2013
- 510(k) K001454 June 2000
Procedures that use guidewires
Frequently asked questions
What is X-pedion 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 X-pedion?
X-pedion is made by Micro Therapeutics, Inc.. It is listed under guidewires in our device library.
What sizes does X-pedion come in?
Sizes listed for X-pedion: Length: 200 cm. Confirm availability with the manufacturer's instructions for use.
Is X-pedion MRI safe?
The FDA device database entry for X-pedion does not state its MRI safety status. Check the labeling before MRI.
Is X-pedion FDA cleared?
X-pedion is covered by FDA submissions K001454, K193548, K201690, K124007.
How do I contact a Micro Therapeutics, Inc. sales representative?
Micro Therapeutics, Inc. has not listed representatives on LA Vascular yet. Visit the Micro Therapeutics, 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.