Guidewires
Volo
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.
Volo 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 |
|---|---|---|---|
| 14-200-001 | — | MR Unsafe | Available |
| 14-200-002 | — | MR Unsafe | Available |
| 14-300-001 | — | MR Unsafe | Available |
| 14-300-002 | — | MR Unsafe | Available |
FDA clearances
- 510(k) K181828 August 2018
Procedures that use guidewires
Frequently asked questions
What is Volo 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 Volo?
Volo is made by Scientia Vascular LLC. It is listed under guidewires in our device library.
What sizes does Volo come in?
The FDA device database does not list sizes for Volo. Check the instructions for use or ask a Scientia Vascular LLC representative.
Is Volo MRI safe?
The FDA device database lists Volo as MR Unsafe. Always follow the specific MRI conditions in the labeling.
Is Volo FDA cleared?
Volo is covered by FDA submission K181828.
How do I contact a Scientia Vascular LLC sales representative?
Scientia Vascular LLC has not listed representatives on LA Vascular yet. Visit the Scientia Vascular LLC 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.