SENDERO MAX Delivery Catheter

The SENDERO MAX Delivery Catheter is a single-lumen, variable-stiffness catheter with a hydrophilic coating designed for percutaneous placement in peripheral blood vessels. It is used to deliver diagnostic and therapeutic agents to target sites under fluoroscopic guidance, with a radiopaque marker on the distal end and a Luer-lock hub on the proximal end.

The device shares the same fundamental design as its predicates: single lumen, variable stiffness construction, radiopaque distal markers, Luer-lock proximal hubs, and hydrophilic coating for reduced friction. All design characteristics of the SENDERO MAX are present in either the primary predicate (SENDERO Microcatheter K240384) or reference predicate (Envoy K140080), with any minor differences covered by the reference predicate.

ISO 10555-1 (burst pressure, tensile strength, flowrate); ISO 80369-7 (hub testing); ASTM F640 (radiopacity); ISO 10993-1 (biocompatibility); plus dimensional inspection, coating thickness and lubricity, simulated use, coating integrity, compatibility, kink diameter, torque, particulate, and packaging validation testing.

The SENDERO MAX is substantially equivalent because it has identical indications for use as the predicate (peripheral vasculature infusion of diagnostic and therapeutic agents), identical principle of operation (percutaneous placement under fluoroscopy), and all fundamental design characteristics (single lumen, variable stiffness, radiopaque markers, hydrophilic coating) present in the predicate devices. Non-clinical performance testing across 15 categories demonstrates the device meets or exceeds predicate performance standards, and any minor design differences are covered by the reference predicate.