COMBICATH CATHETER

COMBICATH CATHETER is an FDA 510(k)-cleared medical device (K974642) manufactured by Plastimed Laboratoire Pharmaceutique. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 12, 1998. Regulation: 8.