510(k) K063563

CORDIS AMILA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETER by Cordis Europa, N.V. — Product Code LIT

K063563 is an FDA 510(k) premarket notification submitted by Cordis Europa, N.V. for the device "CORDIS AMILA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETER". The FDA issued a decision of Substantially Equivalent on March 7, 2007. The device falls under product code LIT (Catheter, Angioplasty, Peripheral, Transluminal), a Class II device regulated under 21 CFR 870.1250. Cordis Europa, N.V. has at least 6 other 510(k) clearances on record.