Guidewires
F-18 Flex
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.
F-18 Flex 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 |
|---|---|---|---|
| F18F04ST190 | Length 190 cm; Outer Diameter 0.018 in | Not stated | Available |
| F18F04ST235 | Length 235 cm; Outer Diameter 0.018 in | Not stated | Available |
| F18F04ST300 | Length 300 cm; Outer Diameter 0.018 in | Not stated | Available |
| F18F04ST400 | Length 400 cm; Outer Diameter 0.018 in | Not stated | Available |
FDA clearances
- 510(k) K240460 June 2024
- 510(k) K212268 May 2022
Procedures that use guidewires
Frequently asked questions
What is F-18 Flex 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 F-18 Flex?
F-18 Flex is made by Fmd Co., Ltd.. It is listed under guidewires in our device library.
What sizes does F-18 Flex come in?
Sizes listed for F-18 Flex: Length: 190–400 cm; Outer Diameter: 0.02 in. Confirm availability with the manufacturer's instructions for use.
Is F-18 Flex MRI safe?
The FDA device database entry for F-18 Flex does not state its MRI safety status. Check the labeling before MRI.
Is F-18 Flex FDA cleared?
F-18 Flex is covered by FDA submissions K212268, K240460.
How do I contact a Fmd Co., Ltd. sales representative?
Fmd Co., Ltd. has not listed representatives on LA Vascular yet. Visit the Fmd 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.