510(k) Report

Devices descending from K031948

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K051405Regensis Pericardial PatchCormatrix Cardiovascular, Inc.200515—
+1K040835Peripatch Sheet, Models 1.5P8, 1.5P16, 4P4, 4P6, 6P8 and 10P16Pm Devices, Inc.200417—
+1K033985Peripatch Sleeve, Models G35, E35, G45, E45, G60, E60, 5C6, 5C8, 5C10Pm Devices, Inc.20041—
+2K210331CardiaMend Pericardial and Epicardial Reconstruction MatrixHelios Cardio, Inc.20210—
+2K190882XenoSure Biologic PatchLemaitre Vascular20200—
+2K191734MatriStem UBM Pericardial PatchAcell, Inc.20190—
+2K182493Bovine Pericardial Tissue PatchTisgenx20190—
+2K122306Synovis Collagen Matrix (TBD)Synovis Surgical Innovations20130—
+2K103356Pruitt Carotid KitLeMaitre Vascular, Inc.20100—
+2K090637Cardio-WrapMast Biosurgery USA, Inc.20100—
+2K090288Orthadapt PRPegasus Biologics, Inc.20097—
+2K082139Edwards Bovine Pericardial Patch, Model 4700Edwards Lifesciences, LLC20085—
+2K063556Peripatch Endo-SleevePm Devices, Inc.20070—
+2K063349Cormatrix Patch for Cardiac Tissue RepairCormatrix Cardiovascular, Inc.200711—
+3K172660Duravess bovine pericardial vascular patchEdwards Lifesciences, LLC20170—
+3K152127CorMatrix TykeCormatrix Cardiovascular, Inc.20162—
+3K140306Cormatrix Protect Ecm EnvelopeCormatrix Cardiovascular, Inc.201442
+3K140789Cormatrix Ecm for Vascular RepairCormatrix Cardiovascular, Inc.20140—
+3K130872CardiocelCelxcel Pty, Ltd.20143—
+3K120479MTF FasciaMusculoskeletal Transplant Foundation20120—
+3K112786Proseries Bioimplants-Proankle/ProcuffSynovis Orthopedic and Woundcare, Inc.20115—
+3K111187Patch, Pledget and IntracardiacCormatrix Cardiovascular, Inc.20111—
+3K081438Matracell Decellularized Pulmonary Artery Patch AllograftLifenet Health20080—
+4K220091Poly-Tape/Infinity-Lock Soft Tissue Reinforcement DeviceXiros, Ltd.20224—
+4K200566ADAPT TissueAdmedus Regen Pty, Ltd.20200—
+4K181038CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single…Cormatrix Cardiovascular, Inc.20181—
+4K173242CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.201731
+4K170951CardioCel 3DAdmedus Regen Pty, Ltd.20170—
+4K162579VascuCelAdmedus Regen Pty, Ltd.20161—
+5K261621TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20261—
+5K251063TekBrace Solo Soft Tissue Reinforcement DeviceTheramicro20252—
+5K230671Pitch PaSoft Tissue Reinforcement DeviceXiros, Ltd.20230—
+5K182255CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro…Aziyo Biologics, Inc.201821
+6K262729TeKBrace Solo Soft Tissue Reinforcement DeviceTheramicro20260—
+6K192616CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.20191—
+7K201313CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.20200—