SULZER CARBOMEDICS CARDIOFIX PERICARDIUM

SULZER CARBOMEDICS CARDIOFIX PERICARDIUM is an FDA 510(k)-cleared medical device (K993288) manufactured by Sulzer Carbomedics, 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 December 28, 1999. Regulation: 8.