Radical 6F Access Catheter

The Radical 6F Access Catheter is a sterile, single-use intravascular catheter designed to facilitate the introduction of other catheters into peripheral, coronary, and neuro vasculature during interventional procedures. It features variable stiffness along its length using hybrid ribbon technology, a hydrophilic coating on the distal region, and is available in working lengths from 80 to 115 cm with a 6 French outer diameter.

The subject device differs from the predicate (Radical the Dude 7F Guide Catheter) only in smaller inner and outer diameters (0.072 inches vs. 0.082 inches inner diameter) and shorter available lengths (includes 80, 90, 100, 110 cm options vs. 95, 105, 115 cm only). Both devices share identical materials, construction methods, sterilization approach, hydrophilic coating, and components including peel-away sheath and rotating hemostasis valve.

Testing referenced ISO 10555-1 (catheters for intravascular use) for burst, liquid leak, air leak, and corrosion testing. Biocompatibility assessment followed ISO 10993-1 (biological evaluation of medical devices). Sterilization validation used ethylene oxide with sterility assurance level of 10⁻⁶.

Substantial equivalence is established because the subject and predicate devices have identical intended use, principles of operation, materials, manufacturing processes, and technological characteristics except for minor dimensional changes (smaller diameter and additional length options). Comprehensive bench testing including simulated use, mechanical properties, coating integrity, and biocompatibility confirmed the smaller dimensions do not raise new safety or effectiveness concerns, and no clinical testing was deemed necessary.