PLEURX PLEURAL CATHETER AND DRAINAGE KITS

PLEURX PLEURAL CATHETER AND DRAINAGE KITS is an FDA 510(k)-cleared medical device (K010642) manufactured by Denver Biomedicals, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 19, 2001. Regulation: 8.