ELECATH FLUID-DRAIN ASSEMBLY

ELECATH FLUID-DRAIN ASSEMBLY is an FDA 510(k)-cleared medical device (K803002) manufactured by Electro-Catheter Corp.. 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 21, 1980. Regulation: 8.