ATRIUM ICAST COVERED STENT

ATRIUM ICAST COVERED STENT is an FDA 510(k)-cleared medical device (K050814) manufactured by Atrium Medical Corp.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 5, 2005. Regulation: 8.