510(k) K201377

SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation Catheter by Cordis Corporation — Product Code LIT

K201377 is an FDA 510(k) premarket notification submitted by Cordis Corporation for the device "SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation Catheter". The FDA issued a decision of Substantially Equivalent on October 9, 2020. 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.