Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire

These are steerable guidewires (Aristotle 14, 18, 24, and Zoom Wire 14) with shapeable nitinol tips designed to introduce and position catheters and other interventional devices in the neuro and peripheral vasculatures. Each guidewire is supplied sterile for single use in various diameters (0.014", 0.018", 0.024"), stiffness profiles, and lengths (200 cm or 300 cm), with a radiopaque platinum marker coil for fluoroscopic visualization.

The subject devices share the same core design, materials (stainless steel core, nitinol tip), dimensions, stiffness profiles, and operating principle as their respective predicates. The primary identified difference is a new hydrophilic coating formulation on the distal end; shelf life differs (1 year vs. 3 years). The Aristotle models and Zoom Wire 14 also include a shaping mandrel accessory with each unit.

ISO 10993 series (biocompatibility), ISO 14971:2019 (risk management), ISO 13485 (quality management system), ISO 11070:2014 (sterile single-use intravascular introducers and guidewires), and FDA guidance document 'Coronary, Peripheral and Neurovascular Guidewires – Performance Tests and Recommended Labeling' (2019).

The devices are substantially equivalent because they have identical intended use and indications for use as their respective predicates, share the same basic design and materials, and the single identified technological difference—a different hydrophilic coating formulation—does not raise new safety or effectiveness concerns. Comprehensive biocompatibility and bench performance testing demonstrated the subject devices perform as intended and are equivalent to their predicate devices.