510(k) K221339

Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection by Contego Medical, Inc. — Product Code LIT

K221339 is an FDA 510(k) premarket notification submitted by Contego Medical, Inc. for the device "Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection". The FDA issued a decision of Substantially Equivalent on June 9, 2022. The device falls under product code LIT (Catheter, Angioplasty, Peripheral, Transluminal), a Class II device regulated under 21 CFR 870.1250. Contego Medical, Inc. has at least 6 other 510(k) clearances on record.