Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist Radial Access Selective Catheter

Three percutaneous catheters for vascular access: the Rist™ 079 and Rist™ 071 Radial Access Guide Catheters are indicated for introducing interventional devices into peripheral, coronary, and neuro vasculature via transradial access. The Rist™ Radial Access Selective Catheter serves the same purpose but can additionally facilitate diagnostic agent introduction in neuro vasculature only, not in coronary or peripheral arteries.

The devices are single-lumen catheters with reinforced shafts (stainless steel braid or coil/nitinol combinations), radiopaque markers, and hydrophilic coatings on the distal 25 cm. The 079 and 071 have PTFE-lined lumens and come with radial access dilators. They are identical in design, materials, dimensions, sterilization method (ethylene oxide), and shelf life (36 months) to their respective predicates.

ANSI/AAMI HE75:2009/(R) 2018 was used for in-vitro simulated use bench testing to evaluate device performance in a clinically representative radial access model.

The labeling changes introduce only additional warnings, precautions, and complications along with clarifications in directions for use—there is no change to indications, design, materials, or fundamental technology compared to predicates K191551, K211990, and K201682. Non-clinical bench testing confirmed the devices meet acceptance criteria, demonstrating these labeling revisions do not raise new safety or effectiveness questions and therefore support substantial equivalence.