ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R2000-CMS

ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R2000-CMS is an FDA 510(k)-cleared medical device (K010390) manufactured by Acist Medical 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 March 8, 2001. Regulation: 8.