DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER

DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER is an FDA 510(k)-cleared medical device (K011020) manufactured by Denver Biomedicals, Inc.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 31, 2001. Regulation: 8.