BOSS 8F Balloon Guide Catheter

BOSS 8F Balloon Guide Catheter is an FDA 510(k)-cleared medical device (K203840) manufactured by Marblehead 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 January 27, 2021. Regulation: 8.