EVERT-O-CATH CATHETER

EVERT-O-CATH CATHETER is an FDA 510(k)-cleared medical device (K922455) manufactured by American Biomaterials 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 July 6, 1994. Regulation: 8.