Guidewires
Agility
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.
Agility 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 |
|---|---|---|---|
| 614-178 | Length 195 cm; Length 10 cm | Not stated | Available |
| 614-179 | Length 195 cm; Length 10 cm | Not stated | Available |
| 614-481 | Length 205 cm; Length 10 cm | Not stated | Available |
| 614-482 | Length 205 cm; Length 20 cm | Not stated | Available |
| 614-491 | Length 10 cm | Not stated | Available |
| 614-541 | Length 175 cm; Length 8 cm | Not stated | Available |
| 614-542 | Length 175 cm; Length 10 cm | Not stated | Available |
| 614-581 | Length 205 cm; Length 8 cm | Not stated | Available |
FDA clearances
- 510(k) K133625 February 2014
Procedures that use guidewires
Frequently asked questions
What is Agility 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 Agility?
Agility is made by Cerenovus, Inc.. It is listed under guidewires in our device library.
What sizes does Agility come in?
Sizes listed for Agility: Length: 8–205 cm. Confirm availability with the manufacturer's instructions for use.
Is Agility MRI safe?
The FDA device database entry for Agility does not state its MRI safety status. Check the labeling before MRI.
Is Agility FDA cleared?
Agility is covered by FDA submission K133625.
How do I contact a Cerenovus, Inc. sales representative?
Cerenovus, Inc. has not listed representatives on LA Vascular yet. Visit the Cerenovus, 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.