Enroute 0.014'' Transcarotid Guidewire

The Enroute Transcarotid 0.014'' Guidewire is a disposable medical device consisting of a PTFE-coated stainless steel core wire with a tapered distal section, platinum tungsten spring coil for radiopacity, and hydrophilic coating for lubricity. It is intended for use as a guide wire in peripheral vasculature, including the carotid artery.

The device has the same design, materials, dimensions, and construction method as the predicate Enroute 0.014'' Guidewire. The primary change is the source of the PTFE coating material, which was switched to an alternative supplier due to the original supplier exiting the market. The coating is applied to the same 95cm stainless steel core with centerless grinding and flattened distal tip.

Testing followed FDA guidance document 16007 (Coronary, Peripheral and Neurovascular Guidewires Performance Tests and Recommended Labeling, October 10, 2019) and ISO 10993-1 for biocompatibility. Tests included pre-conditioning, dimensional verification, visual inspection, coating integrity, catheter compatibility, particulate residue evaluation, and lubricity testing.