510(k) K212167

R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire by Vascular Solutions, LLC — Product Code DQX

K212167 is an FDA 510(k) premarket notification submitted by Vascular Solutions, LLC for the device "R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire". The FDA issued a decision of Substantially Equivalent on February 9, 2022. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Vascular Solutions, LLC has at least 10 other 510(k) clearances on record.