510(k) K141118

NANOCROSS EITE 0.014 OVER-THE-WIRE PTA BALLOON DILATATION CATHETER by Ev3, Inc. — Product Code LIT

K141118 is an FDA 510(k) premarket notification submitted by Ev3, Inc. for the device "NANOCROSS EITE 0.014 OVER-THE-WIRE PTA BALLOON DILATATION CATHETER". The FDA issued a decision of Substantially Equivalent on July 18, 2014. The device falls under product code LIT (Catheter, Angioplasty, Peripheral, Transluminal), a Class II device regulated under 21 CFR 870.1250. Ev3, Inc. has at least 10 other 510(k) clearances on record.