510(k) K011020

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

K011020 is an FDA 510(k) premarket notification submitted by Denver Biomedicals, Inc. for the device "DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER". The FDA issued a decision of Substantially Equivalent on June 1, 2001. The device falls under product code KPM (Shunt, Peritoneal), a Class II device regulated under 21 CFR 876.5955. Denver Biomedicals, Inc. has at least 9 other 510(k) clearances on record.