87 NeuGlide Catheter

The 87 NeuGlide Catheter is a single-lumen guide catheter designed to introduce interventional devices into peripheral, coronary, and neurovasculature. It features a hydrophilic coating, a soft distal tip with radiopaque marker, and is compatible with 0.035-inch or smaller guidewires. The device is supplied sterile and single-use, with inner diameter of 0.087 inches (6F compatible) and available in 100 and 110 cm working lengths.

The subject device has a straight atraumatic tip design compared to the predicate's beveled distal edge; slightly smaller distal outer diameter (0.100 inches vs. 0.106 inches) and inner diameter (0.087 inches vs. 0.088 inches); comparable length range (100–110 cm vs. 80–110 cm); same hydrophilic coating, materials, sterilization method (EO, SAL 10⁻⁶), and packaging approach; includes a loading tool accessory instead of a rotating hemostasis valve.

ISO 10555-1 (catheters), ISO 10993 series (biocompatibility: cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, hemocompatibility), ISO 80369-7 and -20 (luer compatibility), ASTM F756 (hemolysis), ASTM F640-23 (radiopacity), ASTM F1980 (accelerated aging), ISO 11135 (ethylene oxide sterilization), and FDA guidance for PTA and specialty catheters.

The subject and predicate devices share identical intended use (introducing interventional devices into peripheral, coronary, and neurovasculature), same regulatory classification (Class II, QJP/DQY, 21 CFR 870.1250), same materials and sterilization method, and equivalent performance across all bench-tested parameters including trackability, flexibility, kink resistance, compatibility with guidewires and interventional devices, bond strength, leakage resistance, pushability, and burst pressure. Minor dimensional differences (0.001–0.006 inches) and tip design variation (straight vs. beveled) do not materially affect function, as evidenced by comparable distal tip flexibility and torque strength testing. Comprehensive biocompatibility testing demonstrates equivalent safety profiles, establishing substantial equivalence despite minor design refinements.