
Mast Biosurgery USA, Inc.
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CARDIO-WRAP is an FDA 510(k)-cleared medical device (K090637) manufactured by Mast Biosurgery USA, 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 6, 2010. Regulation: 8.