Guidewires
SavvyWire
by Opsens Inc
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.
SavvyWire 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 |
|---|---|---|---|
| Small | Length 280 cm | MR Unsafe | Available |
| X-Small | — | MR Unsafe | Available |
FDA clearances
- 510(k) K213854 September 2022
Procedures that use guidewires
Frequently asked questions
What is SavvyWire 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 SavvyWire?
SavvyWire is made by Opsens Inc. It is listed under guidewires in our device library.
What sizes does SavvyWire come in?
Sizes listed for SavvyWire: Length: 280 cm. Confirm availability with the manufacturer's instructions for use.
Is SavvyWire MRI safe?
The FDA device database lists SavvyWire as MR Unsafe. Always follow the specific MRI conditions in the labeling.
Is SavvyWire FDA cleared?
SavvyWire is covered by FDA submission K213854.
How do I contact a Opsens Inc sales representative?
Opsens Inc has not listed representatives on LA Vascular yet. Visit the Opsens 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.