510(k) K093750

ECHELON MICRO CATHETER, MARATHON MICRO CATHETER, NAUTICA MICRO CATHETER ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, REBA by Ev3, Inc. — Product Code KRA

K093750 is an FDA 510(k) premarket notification submitted by Ev3, Inc. for the device "ECHELON MICRO CATHETER, MARATHON MICRO CATHETER, NAUTICA MICRO CATHETER ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, REBA". The FDA issued a decision of Substantially Equivalent on December 9, 2009. 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.