ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CL1OOH

ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CL1OOH is an FDA 510(k)-cleared medical device (K993774) 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 December 6, 1999. Regulation: 8.