Mirage Hydrophilic Guidewire; X-pedion Hydrophilic Guidewire

Mirage Hydrophilic Guidewire; X-pedion Hydrophilic Guidewire is an FDA 510(k)-cleared medical device (K201690) manufactured by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 20, 2020. Regulation: 8.