510(k) K132777

NANOCROSS ELITE .14 OVER-THE-WIRE PTA, BALLOON DILATION CATHETER by Ev3, Inc. — Product Code LIT

K132777 is an FDA 510(k) premarket notification submitted by Ev3, Inc. for the device "NANOCROSS ELITE .14 OVER-THE-WIRE PTA, BALLOON DILATION CATHETER". The FDA issued a decision of Substantially Equivalent on September 26, 2013. 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.