510(k) K110319

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

K110319 is an FDA 510(k) premarket notification submitted by Ev3, Inc. for the device "EVERCROSS 0.035 OTW PTA DILATATION CATHETER". The FDA issued a decision of Substantially Equivalent on April 14, 2011. 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.