510(k) K100063

HYPERFORM OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER MODEL by Ev3, Inc. — Product Code MJN

K100063 is an FDA 510(k) premarket notification submitted by Ev3, Inc. for the device "HYPERFORM OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER MODEL". The FDA issued a decision of Substantially Equivalent on February 2, 2010. The device falls under product code MJN (Catheter, Intravascular Occluding, Temporary), a Class II device regulated under 21 CFR 870.4450. Ev3, Inc. has at least 10 other 510(k) clearances on record.