
Denver Biomedical, Inc.
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PLEURX PLEURAL CATHETER KIT, MODEL 50-7000 is an FDA 510(k)-cleared medical device (K052436) manufactured by Denver Biomedical, 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 October 5, 2005. Regulation: 8.