510(k) Report

Devices descending from K082139

5 later devices reach Edwards Bovine Pericardial Patch, Model 4700 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172660Duravess bovine pericardial vascular patchEdwards Lifesciences, LLC20170—
+1K130872CardiocelCelxcel Pty, Ltd.20143—
+2K200566ADAPT TissueAdmedus Regen Pty, Ltd.20200—
+2K170951CardioCel 3DAdmedus Regen Pty, Ltd.20170—
+2K162579VascuCelAdmedus Regen Pty, Ltd.20161—