Guidewires
Sunmed Guide Wires
by Sunny Medical Device (Shenzhen) Co., Ltd.
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.
Sunmed Guide Wires 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 |
|---|---|---|---|
| J-tip, 0.035"x145cm, PTFE Coated | Length 145 cm | Not stated | Available |
| J-tip, 0.035"x200cm, PTFE Coated | Length 200 cm | Not stated | Available |
| J tip, 0.035in, 150cm | Length 150 cm | Not stated | Available |
| J tip, 0.035in, 175cm | Length 175 cm | Not stated | Available |
| J tip, 0.035in, 260cm | Length 260 cm | Not stated | Available |
| S-tip, 0.035"x145cm, Hydrophilic Coated | Length 145 cm | Not stated | Available |
| S tip, 0.035in, 145cm | Length 145 cm | Not stated | Available |
| S tip, 0.035in, 150cm | Length 150 cm | Not stated | Available |
| S tip, 0.035in, 260cm | Length 260 cm | Not stated | Available |
FDA clearances
- 510(k) K120119 May 2012
Procedures that use guidewires
Frequently asked questions
What is Sunmed Guide Wires 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 Sunmed Guide Wires?
Sunmed Guide Wires is made by Sunny Medical Device (Shenzhen) Co., Ltd.. It is listed under guidewires in our device library.
What sizes does Sunmed Guide Wires come in?
Sizes listed for Sunmed Guide Wires: Length: 145–260 cm. Confirm availability with the manufacturer's instructions for use.
Is Sunmed Guide Wires MRI safe?
The FDA device database entry for Sunmed Guide Wires does not state its MRI safety status. Check the labeling before MRI.
Is Sunmed Guide Wires FDA cleared?
Sunmed Guide Wires is covered by FDA submission K120119.
How do I contact a Sunny Medical Device (Shenzhen) Co., Ltd. sales representative?
Sunny Medical Device (Shenzhen) Co., Ltd. has not listed representatives on LA Vascular yet. Visit the Sunny Medical Device (Shenzhen) Co., 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.