510(k) K141965

PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT by Care Fusion — Product Code DWM

K141965 is an FDA 510(k) premarket notification submitted by Care Fusion for the device "PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT". The FDA issued a decision of Substantially Equivalent on July 2, 2015. 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.