510(k) Report

Devices descending from K040835

17 later devices reach Peripatch Sheet, Models 1.5P8, 1.5P16, 4P4, 4P6, 6P8 and 10P16 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190882XenoSure Biologic PatchLemaitre Vascular20200—
+1K182493Bovine Pericardial Tissue PatchTisgenx20190—
+1K103356Pruitt Carotid KitLeMaitre Vascular, Inc.20100—
+1K090288Orthadapt PRPegasus Biologics, Inc.20097—
+1K082139Edwards Bovine Pericardial Patch, Model 4700Edwards Lifesciences, LLC20085—
+2K172660Duravess bovine pericardial vascular patchEdwards Lifesciences, LLC20170—
+2K130872CardiocelCelxcel Pty, Ltd.20143—
+2K120479MTF FasciaMusculoskeletal Transplant Foundation20120—
+2K112786Proseries Bioimplants-Proankle/ProcuffSynovis Orthopedic and Woundcare, Inc.20115—
+3K220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+3K200566ADAPT TissueAdmedus Regen Pty, Ltd.20200—
+3K170951CardioCel 3DAdmedus Regen Pty, Ltd.20170—
+3K162579VascuCelAdmedus Regen Pty, Ltd.20161—
+4K261621TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20261—
+4K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20252—
+4K230671Pitch PaSoft Tissue Reinforcement DeviceXiros, Ltd.20230—
+5K262729TeKBrace Solo Soft Tissue Reinforcement DeviceTheramicro20260—