510(k) K170405

BD Curve Ascites Shunt by Care Fusion — Product Code KPM

K170405 is an FDA 510(k) premarket notification submitted by Care Fusion for the device "BD Curve Ascites Shunt". The FDA issued a decision of Substantially Equivalent (kit) on November 2, 2017. The device falls under product code KPM (Shunt, Peritoneal), a Class II device regulated under 21 CFR 876.5955. Care Fusion has at least 10 other 510(k) clearances on record.