510(k) K222690

SmartGUIDE deflectable hydrophilic guidewire by Artiria Medical SA — Product Code MOF

K222690 is an FDA 510(k) premarket notification submitted by Artiria Medical SA for the device "SmartGUIDE deflectable hydrophilic guidewire". The FDA issued a decision of Substantially Equivalent on April 24, 2023. The device falls under product code MOF (Guide, Wire, Catheter, Neurovasculature), a Class II device regulated under 21 CFR 870.1330.