510(k) K181529

Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection by Contego Medical, LLC — Product Code LIT

K181529 is an FDA 510(k) premarket notification submitted by Contego Medical, LLC for the device "Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection". The FDA issued a decision of Substantially Equivalent on December 6, 2018. The device falls under product code LIT (Catheter, Angioplasty, Peripheral, Transluminal), a Class II device regulated under 21 CFR 870.1250. Contego Medical, LLC has at least 6 other 510(k) clearances on record.