VersaD Delivery Catheter

The VersaD Delivery Catheter is a single-lumen, variable stiffness catheter with a long tapered tip and hydrophilic coating, designed for use with compatible guide catheters. It is intended to facilitate the insertion and guidance of catheters into selected blood vessels in the neuro and peripheral vascular systems.

The subject device has a 0.019" inner diameter and proximal/distal outer diameters of 0.062"/0.082", compared to the predicate's 0.062"/0.080". The VersaD uses a Pebax luer and barium sulfate-filled markers, while the predicate uses polycarbonate luer and tungsten markers. Both have 90 cm hydrophilic coating, stainless steel/Pebax shaft construction, and EO sterilization. The VersaD working length is 140 cm versus the predicate's 151 cm.

ISO 10993-1 (biocompatibility), ISO 10993-5 (cytotoxicity), ISO 10993-23 (irritation), ISO 10993-10 (sensitization), ISO 10993-11 (systemic toxicity), ISO 10993-4 (thrombogenicity), ASTM F756 (hemolysis), ASTM 2382 and 2888 (coagulation and platelet assays), USP <151> (pyrogenicity), and bench testing for dimensional, mechanical, and functional performance.

Both devices are percutaneous catheters with identical intended use for neuro and peripheral vascular access, same regulatory classification, shared core materials (stainless steel, Pebax, hydrophilic coating), and equivalent hydrophilic coating length. Performance testing demonstrated the VersaD meets all bench criteria and produces similar or comparable results on critical parameters (tip stiffness, particulate generation, delivery/retrieval forces). Biocompatibility results are equivalent across all tests. Minor design differences (marker material, luer material, dimensional variations) do not raise new safety or effectiveness questions because the device performs substantially identically in simulated use and demonstrates equivalent blood compatibility.