Dual Lumen Extended Length Catheter (dELC), 6F, 12cm (320101); Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102)

The Dual Lumen Extended Length Catheter (dELC) is a 6F reverse-tapered dual lumen venous access device with stainless steel coil reinforcement, designed for peripheral venous access. It is indicated for use up to 72 hours with Aquadex FlexFlow® and Aquadex SmartFlow® systems for ultrafiltration therapy in adult patients with fluid overload, and is not intended for medication infusion, fluid infusion, laboratory sampling, or pediatric use.

The subject device is nearly identical to the predicate, with one material modification: the Female Luer Lock Connector material changed from Cryolite G-20 acrylic to Tritan™ copolyester MX731 (a polyester copolymer). The connector geometry remains identical, and all other design features—including the radiopaque polyurethane shaft, double-D lumen configuration, reverse-tapered design, coil reinforcement, ISO 80369-compliant connectors, and MRI-unsafe designation—are unchanged.

Not stated in this summary.

The material substitution in the Female Luer Lock Connector does not raise different questions of safety and effectiveness because the new copolyester material has a similar biocompatibility profile to the predicate acrylic, maintains an identical mechanism of action, and preserves unchanged intended use and technological characteristics. Nonclinical testing confirmed the new material introduces no new risks related to adverse tissue reactions, ethylene oxide residuals, or shelf-life, and functionality testing demonstrated connector integrity and device effectiveness remained intact through visual inspection, leakage testing, and tensile force validation.