ACS ROTATING HEMO VALVE - DUAL ACCESS TYPE

ACS ROTATING HEMO VALVE - DUAL ACCESS TYPE is an FDA 510(k)-cleared medical device (K861847) manufactured by Advanced Cardiovascular Systems, 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 June 15, 1986. Regulation: 8.