PREMICA CT CONTRAST MEDIA DELIVERY SYSTEM

PREMICA CT CONTRAST MEDIA DELIVERY SYSTEM is an FDA 510(k)-cleared medical device (K983314) manufactured by Nycomed Amersham Imaging. 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 18, 1999. Regulation: 8.