HEMASHIELD VANTAGE (VASCULAR GRAFT

HEMASHIELD VANTAGE (VASCULAR GRAFT is an FDA 510(k)-cleared medical device (K961847) manufactured by Meadox Medicals, Div. Boston Scientific 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 January 21, 1997. Regulation: 8.