510(k) K112831

PLEURX PLEURAL CATHETER SYSTEMS by Care Fusion — Product Code DWM

K112831 is an FDA 510(k) premarket notification submitted by Care Fusion for the device "PLEURX PLEURAL CATHETER SYSTEMS". The FDA issued a decision of Substantially Equivalent on February 16, 2012. The device falls under product code DWM (Apparatus, Suction, Patient Care), a Class II device regulated under 21 CFR 870.5050. Care Fusion has at least 10 other 510(k) clearances on record.