8F FlowGate2 Balloon Guide Catheter

8F FlowGate2 Balloon Guide Catheter is an FDA 510(k)-cleared medical device (K153729) manufactured by Concentric Medical. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 26, 2016. Regulation: 8.