Carrier XL Delivery Catheter

The Carrier XL Delivery Catheter is a single-lumen, variable-stiffness composite catheter with a hydrophilic coating designed for general intravascular use in peripheral, coronary, and neurovasculature. It is intended to infuse diagnostic agents such as contrast media and assist in delivering interventional devices like distal access catheters, particularly in the neurovasculature.

The subject device has a maximum outer diameter of 0.077" (1.96 mm), compared to the predicate's 0.069" (1.75 mm). Both share the same inner diameter (0.021"), coating length (60 cm), hydrophilic coating, packaging configuration, and sterilization method (ethylene oxide). The subject device offers usable lengths of 142 cm, 152 cm, or 162 cm, while the predicate offers 152 cm only.

ISO 10993-1 for biocompatibility evaluation of medical devices; FDA guidance on biological evaluation within a risk management process. Testing included design validation/usability, tip buckling, dimensional verification, kink resistance, and flow rate characterization.

The Carrier XL Delivery Catheter is substantially equivalent to the predicate NG Delivery Catheter (K230609) based on identical indications for use, similar technological characteristics using the same materials and sterilization methods, and successful non-clinical bench testing demonstrating comparable performance. Dimensional differences do not raise new questions of safety or effectiveness.