510(k) K122422

PLEURX PLEURAL CATHETER SYSTEM PLEURX CATHETER ACCESS KIT PLEURX SLIDE VALVED PEELABLE INTRODUCER by Care Fusion — Product Code PNG

K122422 is an FDA 510(k) premarket notification submitted by Care Fusion for the device "PLEURX PLEURAL CATHETER SYSTEM PLEURX CATHETER ACCESS KIT PLEURX SLIDE VALVED PEELABLE INTRODUCER". The FDA issued a decision of Substantially Equivalent (kit) on October 24, 2012. The device falls under product code PNG (Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling), a Class II device regulated under 21 CFR 876.5630. Care Fusion has at least 10 other 510(k) clearances on record.