510(k) K032737

CORDIS POWERFLEX EXTREME PTA BALLOON CATHETER, CORDIS POWERFLEX PLUS PTA BALLOON CATHETER, CORDIS POWERFLEX P3 PTA by Cordis Europa, N.V. — Product Code DQY

K032737 is an FDA 510(k) premarket notification submitted by Cordis Europa, N.V. for the device "CORDIS POWERFLEX EXTREME PTA BALLOON CATHETER, CORDIS POWERFLEX PLUS PTA BALLOON CATHETER, CORDIS POWERFLEX P3 PTA". The FDA issued a decision of Substantially Equivalent on October 2, 2003. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Cordis Europa, N.V. has at least 6 other 510(k) clearances on record.