510(k) K133625

AGILITY 10 STANDARD & SOFT 0.01IN. X 195CM, AGILITY 14 STANDARD & SOFT 0.014IN X 205CM & XL 350CM, AGILITY 16 STANDARD & by Codman & Shurtleff, Inc. — Product Code MOF

K133625 is an FDA 510(k) premarket notification submitted by Codman & Shurtleff, Inc. for the device "AGILITY 10 STANDARD & SOFT 0.01IN. X 195CM, AGILITY 14 STANDARD & SOFT 0.014IN X 205CM & XL 350CM, AGILITY 16 STANDARD &". The FDA issued a decision of Substantially Equivalent on February 24, 2014. The device falls under product code MOF (Guide, Wire, Catheter, Neurovasculature), a Class II device regulated under 21 CFR 870.1330. Codman & Shurtleff, Inc. has at least 10 other 510(k) clearances on record.