SORIN B-CARE5 FOR THE STOCKERT S5 SYSTEM

SORIN B-CARE5 FOR THE STOCKERT S5 SYSTEM is an FDA 510(k)-cleared medical device (K092463) manufactured by Sorin Group Deutschland GmbH. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 4, 2009. Regulation: 8.