510(k) K112797

POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER by Cordis Corp. — Product Code LIT

K112797 is an FDA 510(k) premarket notification submitted by Cordis Corp. for the device "POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER". The FDA issued a decision of Substantially Equivalent on May 4, 2012. The device falls under product code LIT (Catheter, Angioplasty, Peripheral, Transluminal), a Class II device regulated under 21 CFR 870.1250. Cordis Corp. has at least 10 other 510(k) clearances on record.