510(k) K241388

Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist Radial Access Selective Catheter by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular — Product Code QJP

K241388 is an FDA 510(k) premarket notification submitted by Micro Therapeutics, Inc. d/b/a ev3 Neurovascular for the device "Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist Radial Access Selective Catheter". The FDA issued a decision of Substantially Equivalent on January 2, 2025. The device falls under product code QJP (Catheter, Percutaneous, Neurovasculature), 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.