510(k) K011862

DENVER ASCITES SHUNT AND PERCUTANEOUS ACCESS KIT WITH ASCITIES SHUNT by Denver Biomedical, Inc. — Product Code KPM

K011862 is an FDA 510(k) premarket notification submitted by Denver Biomedical, Inc. for the device "DENVER ASCITES SHUNT AND PERCUTANEOUS ACCESS KIT WITH ASCITIES SHUNT". The FDA issued a decision of Substantially Equivalent on July 12, 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.