14F Duo-Flow® Side X Side Double Lumen Catheter

The 14F Duo-Flow® Side X Side Double Lumen Catheter is a radiopaque polyurethane tube with two D-shaped lumens used for short-term central venous access in hemodialysis, apheresis, and infusion. The proximal (red) lumen provides arterial outflow while the distal (blue) lumen provides venous return, with color-coded connectors for identification.

The subject device has identical technological characteristics to the predicate: two segregated lumens with side-holes in each, color-coded female luer connectors, a molded hub transition, barium sulphate for radiopacity, and availability in multiple sizes with curved or straight extensions. The only difference is the subject device introduces a new 14F size, while the predicate was available in 9F, 11F, and 12F sizes.

ISO 10993-1 for biocompatibility evaluation, ISO 80369-7 for stress cracking and luer testing. Bench testing included dimensional analysis, air/liquid leakage, lumen elongation, kink resistance, gravity flow rate, flow versus pressure, priming volume, clamp cycles, simulated use, electrical conductivity, force at break, and packaging validation.

The subject 14F device is substantially equivalent because it maintains identical intended use (short-term central venous access for hemodialysis, apheresis, infusion), identical design principles (two D-shaped segregated lumens with side-holes and color-coded connectors), identical materials (polyurethane with barium sulphate), identical sterilization method (EO), and identical principles of operation. Performance testing demonstrates the 14F size performs comparably to predicate sizes across all measured parameters including flow rates and pressure characteristics. No design or material changes affect safety or effectiveness.