510(k) K122940

ADVANCE MICRO 14 ULTRA LOW PROFILE BALLOON DILATATION CATHETER MODEL PTA3 by Cook, Inc. — Product Code DQY

K122940 is an FDA 510(k) premarket notification submitted by Cook, Inc. for the device "ADVANCE MICRO 14 ULTRA LOW PROFILE BALLOON DILATATION CATHETER MODEL PTA3". The FDA issued a decision of Substantially Equivalent on March 19, 2013. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Cook, Inc. has at least 10 other 510(k) clearances on record.