510(k) K082139

EDWARDS BOVINE PERICARDIAL PATCH, MODEL 4700 by Edwards Lifesciences, LLC — Product Code DXZ

K082139 is an FDA 510(k) premarket notification submitted by Edwards Lifesciences, LLC for the device "EDWARDS BOVINE PERICARDIAL PATCH, MODEL 4700". The FDA issued a decision of Substantially Equivalent on October 23, 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. Edwards Lifesciences, LLC has at least 10 other 510(k) clearances on record.