
Origen Biomedical, Inc.
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ORIGEN REINFORCED DUAL LUMEN CATHETER is an FDA 510(k)-cleared medical device (K113869) manufactured by Origen 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 July 25, 2012. Regulation: 8.