510(k) K180715

React 68 Catheter by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular — Product Code DQY

K180715 is an FDA 510(k) premarket notification submitted by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular for the device "React 68 Catheter". The FDA issued a decision of Substantially Equivalent on July 4, 2018. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Micro Therapeutics, Inc. d/b/a ev3 Neurovascular has at least 10 other 510(k) clearances on record.