CROSSLEAD 0.014inch

The CROSSLEAD 0.014inch is a steerable guide wire designed to direct a catheter to desired anatomical locations in the peripheral vasculature during diagnostic or interventional procedures. It has a maximum diameter of 0.014 inches (0.36mm) and is available in lengths of 100cm, 200cm, 235cm, and 300cm. The device is not intended for neurovascular use.

The device features a hybrid nitinol and stainless-steel core wire with a stainless-steel inner coil and platinum-nickel outer coil. Key differences from the predicate ASAHI Gladius include a modified coil structure and core shape. Like the predicate, it has hydrophilic and hydrophobic coatings, is sterilized via ethylene oxide, and is available in both straight and pre-shaped designs.

Not stated in this summary. The document describes non-clinical laboratory testing performed (tensile strength, torque strength, torqueability, tip flexibility, coating integrity, catheter compatibility, visual inspection, corrosion resistance, kink resistance, radio-detectability, dimensional verification, and acute particulate characterization) but does not cite specific consensus standards or test method numbers.

The device has the same intended use as the predicate (peripheral vascular catheter guidance during diagnostic or interventional procedures). In vitro bench testing demonstrated the subject device met all acceptance criteria and performed similarly to predicate and reference devices. Biocompatibility was confirmed through standard assessment endpoints. Although coil structure and core shape differ, the overall components, materials, sterilization method, shelf life, and operating principles remain substantially similar, establishing functional and safety equivalence.