510(k) K193548

Mirage Hydrophilic Guidewire, X-pedion Hydrophilic Guidewire by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular — Product Code DQX

K193548 is an FDA 510(k) premarket notification submitted by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular for the device "Mirage Hydrophilic Guidewire, X-pedion Hydrophilic Guidewire". The FDA issued a decision of Substantially Equivalent on January 18, 2020. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Micro Therapeutics, Inc. d/b/a ev3 Neurovascular has at least 10 other 510(k) clearances on record.