510(k) K111490

MARKSMAN CATHETER, *REFERS TO DIFFERENT CATHETER WORKING LENGHTS, DISTAL SINGLE COILED LENGTHS AND DISTAL SHAFT LENGTHS by Ev3, Inc. — Product Code KRA

K111490 is an FDA 510(k) premarket notification submitted by Ev3, Inc. for the device "MARKSMAN CATHETER, *REFERS TO DIFFERENT CATHETER WORKING LENGHTS, DISTAL SINGLE COILED LENGTHS AND DISTAL SHAFT LENGTHS". The FDA issued a decision of Substantially Equivalent on September 16, 2011. The device falls under product code KRA (Catheter, Continuous Flush), a Class II device regulated under 21 CFR 870.1210. Ev3, Inc. has at least 10 other 510(k) clearances on record.