ADVANTA SST GRAFT (<6MM)

ADVANTA SST GRAFT (<6MM) is an FDA 510(k)-cleared medical device (K010517) manufactured by Atrium Medical Corp.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 17, 2001. Regulation: 8.