Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter

This 510(k) submission covers six catheter devices: Passeo-35 Xeo (peripheral dilatation), Passeo-18 (peripheral dilatation), Passeo-14 (peripheral dilatation), Oscar (peripheral multifunctional), Pantera Pro (coronary PTCA), and Pantera LEO (coronary PTCA). The peripheral catheters dilate stenotic lesions in iliac, femoral, popliteal, and infrapopliteal arteries, treat arteriovenous dialysis fistulae obstructions, and provide post-stent dilatation. The coronary catheters dilate stenotic portions of coronary arteries or bypass grafts to improve myocardial perfusion and dilate coronary stents.

All subject devices are substantially identical to their predicates across multiple parameters: same classification (Class II), product codes (LIT/LOX), indications, contraindications, sterilization method (EO gas, SAL 10-6), shelf life (3 years), balloon diameters/lengths, nominal pressures, rated burst pressures, guide wire compatibility, introducer sheath compatibility, radiopaque markers (platinum-iridium), and device descriptions (over-the-wire or rapid-exchange balloon catheters). Minor differences noted include Luer connectors being brought into compliance with ISO 80369-7:2021.

ISO 80369-7:2021 (Luer connectors and small-bore connectors for liquids and gases in healthcare applications). The document references that performance testing was conducted to ensure devices conform to design specifications, but specific test methods or other consensus standards (ISO, ASTM, IEC) are not detailed in this summary.

The devices are substantially equivalent because they maintain identical intended uses, contraindications, device descriptions, and all critical performance characteristics (balloon compliance, pressure profiles, dimensions, materials, sterilization) as their respective predicates. Performance testing demonstrated that the materials, manufacturing processes, and component designs meet established specifications necessary for consistent performance during intended use, and the testing showed no new safety or effectiveness issues compared to predicate devices. Minor design modifications do not introduce new safety concerns.