510(k) K202318

Marathon Flow Directed Micro Catheter by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular — Product Code KRA

K202318 is an FDA 510(k) premarket notification submitted by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular for the device "Marathon Flow Directed Micro Catheter". The FDA issued a decision of Substantially Equivalent on September 14, 2020. The device falls under product code KRA (Catheter, Continuous Flush), a Class II device regulated under 21 CFR 870.1210. Micro Therapeutics, Inc. d/b/a ev3 Neurovascular has at least 10 other 510(k) clearances on record.