AFFINITY PIXIE OXYGENATION SYSTEM WITH CARMEDA BIOACTIVE SURFACE OR BALANCE BIOSURFACE

AFFINITY PIXIE OXYGENATION SYSTEM WITH CARMEDA BIOACTIVE SURFACE OR BALANCE BIOSURFACE is an FDA 510(k)-cleared medical device (K100645) manufactured by Medtronic, Inc.. 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 13, 2012. Regulation: 8.