Guidewires
TalWire
A long, thin wire intended to be percutaneously placed into the peripheral vasculature (not heart or central nervous system) to function as a guide for the introduction of devices (e.g., catheters). It is made of metal (e.g., stainless steel, Nitinol), with or without coating, and is available in a variety of distal tip designs. It is intended to be used for percutaneous angiography, angioplasty, rotational atherectomy and thrombectomy, drainage, and other diagnostic and interventional procedures. It may include devices used to facilitate manipulation (e.g., torque device). This is a single-use device.
TalWire 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 |
|---|---|---|---|
| SP-4003-002 | Guidewire Diameter 0.018 in; Guidewire Length 40 cm | Not stated | Available |
| SP-4003-004 | Guidewire Diameter 0.021 in; Guidewire Length 40 cm | Not stated | Available |
| SP-4003-006 | Guidewire Diameter 0.018 in; Guidewire Length 80 cm | Not stated | Available |
| SP-4003-008 | Guidewire Diameter 0.021 in; Guidewire Length 80 cm | Not stated | Available |
FDA clearances
- 510(k) K223791 July 2023
Procedures that use guidewires
Frequently asked questions
What is TalWire used for?
A long, thin wire intended to be percutaneously placed into the peripheral vasculature (not heart or central nervous system) to function as a guide for the introduction of devices (e.g., catheters). It is made of metal (e.g., stainless steel, Nitinol), with or without coating, and is available in a variety of distal tip designs. It is intended to be used for percutaneous angiography, angioplasty, rotational atherectomy and thrombectomy, drainage, and other diagnostic and interventional procedures. It may include devices used to facilitate manipulation (e.g., torque device). This is a single-use device.
Who makes TalWire?
TalWire is made by Embrace Medical Ltd. It is listed under guidewires in our device library.
What sizes does TalWire come in?
Sizes listed for TalWire: Guidewire Diameter: 0.02–0.02 in; Guidewire Length: 40–80 cm. Confirm availability with the manufacturer's instructions for use.
Is TalWire MRI safe?
The FDA device database entry for TalWire does not state its MRI safety status. Check the labeling before MRI.
Is TalWire FDA cleared?
TalWire is covered by FDA submission K223791.
How do I contact a Embrace Medical Ltd sales representative?
Embrace Medical Ltd has not listed representatives on LA Vascular yet. Visit the Embrace Medical Ltd 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.