510(k) K200547

Traxcess 14 SELECT Guidewire by MicroVention, Inc. — Product Code MOF

K200547 is an FDA 510(k) premarket notification submitted by MicroVention, Inc. for the device "Traxcess 14 SELECT Guidewire". The FDA issued a decision of Substantially Equivalent on April 16, 2020. The device falls under product code MOF (Guide, Wire, Catheter, Neurovasculature), a Class II device regulated under 21 CFR 870.1330. MicroVention, Inc. has at least 10 other 510(k) clearances on record.