FUBUKI XF-R Neurovascular Long Sheath

The FUBUKI XF-R Neurovascular Long Sheath is a single-lumen catheter designed to guide interventional devices through blood vessels in the brain and nervous system during minimally invasive procedures. It also allows injection of contrast media for imaging. The device consists of a shaft with a soft tip, a protector, and a connector, coated with a hydrophilic polymer on the outside and fluoropolymer on the inner lumen.

Compared to the predicate FUBUKI XF, the subject device has an extended hydrophilic coating length (20cm vs 8cm), includes a new 95cm long sheath model while removing the 110cm model, excludes the angled-tip variant, and adds a 117cm dilator option. Outer diameter, inner diameter, materials, sterilization method, and general construction remain identical.

FDA guidance on Peripheral PTA and Specialty Catheters 510(k) submissions; ISO 10555-1 (Intravascular Catheters—General Requirements); ISO 10993 series for biocompatibility (cytotoxicity, sensitization, systemic toxicity, hemocompatibility, thrombogenicity); ISO 10993-4 for blood compatibility testing.

The subject device has identical intended use and the same fundamental design, materials, sterilization method, and operating principles as the predicate. The identified differences—longer hydrophilic coating, modified length offerings, and an additional dilator size—do not introduce new safety or effectiveness concerns because they are minor geometric and coating variations that do not alter the basic function or interaction with tissue. Non-clinical testing shows the device meets all acceptance criteria and performs similarly to the predicate, with biocompatibility and thrombogenicity comparable to the predicate device.