510(k) K090849

MODIFICATION TO: NANOCROSS 0.14 OTW PTA DILATATION CATHETER, MODELS AB14W020210090, AB14W020210150 by Ev3, Inc. — Product Code DQY

K090849 is an FDA 510(k) premarket notification submitted by Ev3, Inc. for the device "MODIFICATION TO: NANOCROSS 0.14 OTW PTA DILATATION CATHETER, MODELS AB14W020210090, AB14W020210150". The FDA issued a decision of Substantially Equivalent on May 1, 2009. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Ev3, Inc. has at least 10 other 510(k) clearances on record.