510(k) K103322

EVERCROSS 0.035 OTW PTA DILATION CATHETER by Ev3, Inc. — Product Code LIT

K103322 is an FDA 510(k) premarket notification submitted by Ev3, Inc. for the device "EVERCROSS 0.035 OTW PTA DILATION CATHETER". The FDA issued a decision of Substantially Equivalent on December 6, 2010. 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.