TUBING, CONMNECTORS, AND ACCESSORIES WIT BALANCE BIOSURFACE

TUBING, CONMNECTORS, AND ACCESSORIES WIT BALANCE BIOSURFACE is an FDA 510(k)-cleared medical device (K113845) 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 January 24, 2012. Regulation: 8.