ACIST INJECTOR SYSTEM, MODEL CL100 H

ACIST INJECTOR SYSTEM, MODEL CL100 H is an FDA 510(k)-cleared medical device (K984058) manufactured by Acist Medical Systems. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 10, 1999. Regulation: 8.