510(k) K042187

ECHELON 10,45 TIP SHAPE MICRO CATHETER ECHELON 10,90 TIP SHAPE MICRO CATHETER, ECHELON 14,45 TIP SHAPE MICRO CATHETER,90 by Micro Therapeutics, Inc. — Product Code KRA

K042187 is an FDA 510(k) premarket notification submitted by Micro Therapeutics, Inc. for the device "ECHELON 10,45 TIP SHAPE MICRO CATHETER ECHELON 10,90 TIP SHAPE MICRO CATHETER, ECHELON 14,45 TIP SHAPE MICRO CATHETER,90". The FDA issued a decision of Substantially Equivalent on September 2, 2004. The device falls under product code KRA (Catheter, Continuous Flush), a Class II device regulated under 21 CFR 870.1210. Micro Therapeutics, Inc. has at least 10 other 510(k) clearances on record.