510(k) K133843

SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY DILATATION CATHETER by Cordis Corporation — Product Code LIT

K133843 is an FDA 510(k) premarket notification submitted by Cordis Corporation for the device "SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY DILATATION CATHETER". The FDA issued a decision of Substantially Equivalent on June 27, 2014. 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.