Branchor X Balloon Guide Catheter

The Branchor X Balloon Guide Catheter is a variable stiffness catheter with a distal balloon used to facilitate insertion and guidance of intravascular catheters into neurovascular blood vessels and enable contrast media injection. The balloon provides temporary vascular occlusion during procedures and can serve as a conduit for retrieval devices.

The device features a radiopaque marker at the distal balloon end, branched connector at the proximal end, braid-reinforced lumen, hydrophilic outer coating, and PTFE-coated shaft lumen. Key differences from the predicate include addition of a luer-activated valve in the accessory kit and a shorter shelf life (0.5 years vs. 3 years), though the core materials, design, sterilization method, and operating principles remain the same.

ISO 10993 series for biocompatibility (cytotoxicity, sensitization, irritation, acute toxicity, pyrogenicity, hemolysis, complement activation, thrombogenicity), ISO 11135-1:2014 for sterilization validation, ISO 10993-7:2008 for residual limits, and FDA guidance on International Standard ISO 10993-1 for risk management evaluation.

The subject device shares identical intended use and substantially similar technological characteristics with the predicate device (K221951), including the same component materials, design architecture, braid-reinforced lumen construction, hydrophilic coating, and ethylene oxide sterilization. Comprehensive nonclinical bench testing and biocompatibility assessment demonstrate equivalent or comparable performance across all critical parameters (dimensional, mechanical, flow, electrical, hemocompatibility), and the identified differences (accessory kit composition and shelf life duration) do not raise new safety or effectiveness concerns.