TRI-OPTIC MEASUREMENT CELL; WITH BALANCE BIOSURFACE, WITH CARMEDA BIOACTIVE SURFACE, WITH TRILLIUM BIOSURFACE, WITH 6

TRI-OPTIC MEASUREMENT CELL; WITH BALANCE BIOSURFACE, WITH CARMEDA BIOACTIVE SURFACE, WITH TRILLIUM BIOSURFACE, WITH 6 is an FDA 510(k)-cleared medical device (K133157) 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 October 22, 2014. Regulation: 8.