Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection

Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection is an FDA 510(k)-cleared medical device (K181529) 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 December 5, 2018. Regulation: 8.