R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire

R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire is an FDA 510(k)-cleared medical device (K212167) manufactured by Vascular Solutions, LLC. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 8, 2022. Regulation: 8.