Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin System)

Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin System) is an FDA 510(k)-cleared medical device (K181128) manufactured by Contego Medical, LLC. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 5, 2018. Regulation: 8.