510(k) K012235

DENVER PLEURAL EFFUSION SHUNT AND DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER by Denver Biomedical, Inc. — Product Code KPM

K012235 is an FDA 510(k) premarket notification submitted by Denver Biomedical, Inc. for the device "DENVER PLEURAL EFFUSION SHUNT AND DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER". The FDA issued a decision of Substantially Equivalent on October 4, 2001. The device falls under product code KPM (Shunt, Peritoneal), a Class II device regulated under 21 CFR 876.5955. Denver Biomedical, Inc. has at least 4 other 510(k) clearances on record.