510(k) K962814

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

K962814 is an FDA 510(k) premarket notification submitted by Denver Biomaterials, Inc. for the device "DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER". The FDA issued a decision of Substantially Equivalent on April 14, 1997. The device falls under product code KPM (Shunt, Peritoneal), a Class II device regulated under 21 CFR 876.5955. Denver Biomaterials, Inc. has at least 3 other 510(k) clearances on record.