510(k) K973129

DENVER ASCITES SHUNTS, DENVER ASCITES SHUNT PERCUTANEOUS ACCESS KITS by Denver Biomaterials, Inc. — Product Code KPM

K973129 is an FDA 510(k) premarket notification submitted by Denver Biomaterials, Inc. for the device "DENVER ASCITES SHUNTS, DENVER ASCITES SHUNT PERCUTANEOUS ACCESS KITS". The FDA issued a decision of Substantially Equivalent on March 17, 1998. 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.