CHANGE OF CATHETER BODY MATERIAL (RADIO-OPAQUE NY)

CHANGE OF CATHETER BODY MATERIAL (RADIO-OPAQUE NY) is an FDA 510(k)-cleared medical device (K872485) manufactured by Ideas For Medicine, 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 August 11, 1987. Regulation: 8.