510(k) K121442

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

K121442 is an FDA 510(k) premarket notification submitted by Cordis Corporation for the device "POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER". The FDA issued a decision of Substantially Equivalent on June 14, 2012. The device falls under product code LIT (Catheter, Angioplasty, Peripheral, Transluminal), a Class II device regulated under 21 CFR 870.1250. Cordis Corporation has at least 10 other 510(k) clearances on record.