Broadway 8 Catheter

The Broadway 8 Catheter is a single-lumen, flexible catheter with variable stiffness designed to facilitate insertion and guidance of interventional devices into blood vessels in the neurovascular system. It features a hydrophilic coating at the distal end for reduced friction and includes a radiopaque marker band and luer hub, packaged with a FastPass Delivery Assist Catheter, hemostasis valves, and introducer sheaths.

The Broadway 8 Catheter has a 0.098-inch outer diameter and 0.084-inch inner diameter with a 132 cm effective length, compared to the predicate's 0.083-0.087 inch outer diameter range and 0.071-0.074 inch inner diameter across multiple sizes. Both devices use stainless steel reinforcement and hydrophilic coating, but the subject device lacks strain relief whereas the predicate includes polyolefin strain relief. The subject device uses only stainless steel reinforcement while the predicate uses stainless steel/nitinol combinations.

ISO 10555-1 (tensile strength, liquid/air leak, burst pressure), ISO 10993 series (biocompatibility including hemolysis, thromboresistance, cytotoxicity, sensitization, acute systemic toxicity, pyrogenicity, and intracutaneous reactivity), EN ISO 14971 (risk management), EN ISO 10993-7 (ethylene oxide residuals), and USP <151> (pyrogenicity).

The Broadway 8 Catheter is substantially equivalent to the AXS Vecta Intermediate Catheter because both devices share the same regulatory classification (21 CFR 870.1250, Class II, QJP code), identical indications for neurovascular interventions, common materials (medical-grade plastics/metals with hydrophilic coating), same fundamental design principles as a single-lumen flexible catheter with variable stiffness, and comparable performance in bench testing including particulate generation, coating integrity, and friction force. Additionally, an FDA-compliant GLP animal safety study demonstrated the subject device performed as well as or better than the predicate with no vascular damage, and all biocompatibility testing showed non-adverse results comparable to established safety profiles.