510(k) K081438

MATRACELL DECELLULARIZED PULMONARY ARTERY PATCH ALLOGRAFT by Lifenet Health — Product Code DXZ

K081438 is an FDA 510(k) premarket notification submitted by Lifenet Health for the device "MATRACELL DECELLULARIZED PULMONARY ARTERY PATCH ALLOGRAFT". The FDA issued a decision of Substantially Equivalent on October 17, 2008. The device falls under product code DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene), a Class II device regulated under 21 CFR 870.3470. Lifenet Health has at least 2 other 510(k) clearances on record.