Ryurei

Ryurei is a percutaneous transluminal coronary angioplasty (PTCA) catheter with an inflatable balloon used to dilate stenotic coronary arteries and bypass grafts to improve blood flow, treat acute myocardial infarction, and post-deploy expand balloon-expandable stents. It is available in 1.5 mm diameter (for pre-dilatation and acute MI) and 2.0–4.0 mm diameters (for dilatation, acute MI, and stent post-deployment).

Ryurei incorporates the same basic design as the predicate: an inflatable balloon tip, double-lumen catheter structure with guidewire and inflation lumens, radiopaque markers, hydrophilic polymer coating, and ethylene oxide sterilization. Key differences include additional balloon sizes (5, 10, 15, 20, 30, 40 mm lengths) and balloon diameters (1.5–4.0 mm) compared to some predicates, along with slightly different rated burst pressures (6 atm nominal; 12–14 atm burst depending on diameter).

ISO 10993-1 for biocompatibility; ISO 11135:2014/Amd 1:2018 for ethylene oxide sterilization validation; FDA Guidance for Industry on ISO 10993-1; dimensional verification, balloon compliance, fatigue, torque, flexibility, and simulated-use performance testing.

Ryurei is substantially equivalent to the Sapphire II Pro Balloon Dilatation Catheter because it has the same intended use, operating principle, basic design/construction, sterilization method, and fundamental scientific technology. Performance, biocompatibility, and packaging integrity testing demonstrate equivalence to the predicate, and the Emerge Monorail reference device supports the stent post-deployment expansion indication.