510(k) K181128

Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin System) by Contego Medical, LLC — Product Code LIT

K181128 is an FDA 510(k) premarket notification submitted by Contego Medical, LLC for the device "Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin System)". The FDA issued a decision of Substantially Equivalent on September 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.