NEOCATH 1000 W/HEPCOTE

NEOCATH 1000 W/HEPCOTE is an FDA 510(k)-cleared medical device (K832793) manufactured by Orange Medical Instruments, Inc.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 25, 1983. Regulation: 8.