HEMAQUET(TM) AND HEMAFLEX(TM) INTRODUCERS

HEMAQUET(TM) AND HEMAFLEX(TM) INTRODUCERS is an FDA 510(k)-cleared medical device (K897041) manufactured by C.R. Bard, 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 March 15, 1990. Regulation: 8.