Zenith Micro Guidewire

The Zenith Micro Guidewire is a steerable guidewire with a shapeable tip designed for general intravascular use in neuro and peripheral vasculature. It facilitates selective placement of diagnostic or therapeutic catheters and is explicitly not intended for coronary artery use. The device is supplied sterile for single use only and includes a platinum spring marker coil for fluoroscopic visualization.

The device comes in four series (12, 13, 16, and 18 gauge) with lengths ranging from 110-320 cm. It features a hydrophilic polymer coating distally and PTFE coating proximally, a nitinol woven jacket with TPU protective jacket, and a platinum-nickel alloy radiopaque coil. Key differences from predicates include a shorter shapeable tip length (1 cm vs. 1.4-35 cm) and a 2-year shelf life versus 3 years or 1 year for predicates.

Testing was conducted per FDA guidance on Coronary, Peripheral, and Neurovascular Guidewires (2019), ISO 11070:2014 (sterile single-use intravascular devices), ISO 11135 (ethylene oxide sterilization), and ISO 10993 series standards (biological evaluation including cytotoxicity, sensitization, pyrogenicity, hemolysis, and thrombogenicity).

The Zenith Micro Guidewire is substantially equivalent because it shares the same regulatory classification (Class II), product codes (MOF, DQX), indications for use, and fundamental design (steerable guidewire with shapeable tip for neuro/peripheral vasculature). Bench testing demonstrates equivalent performance in dimensional, mechanical, and functional properties, and biocompatibility testing confirms safety comparable to predicate devices despite minor material and dimensional variations.