510(k) Report

Devices descending from K012098

18 later devices reach Preclude Pericardial Membrane through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240775PeriBeam® Pericardial MembraneTamabio20250—
+1K051405Regensis Pericardial PatchCormatrix Cardiovascular, Inc.200515—
+1K031785Macropore Cardio-Wrap (TS)Macropore Biosurgery, Inc.20031—
+2K210331CardiaMend Pericardial and Epicardial Reconstruction MatrixHelios Cardio, Inc.20210—
+2K191734MatriStem UBM Pericardial PatchAcell, Inc.20190—
+2K122306Synovis Collagen Matrix (TBD)Synovis Surgical Innovations20130—
+2K090637Cardio-WrapMast Biosurgery USA, Inc.20100—
+2K063349Cormatrix Patch for Cardiac Tissue RepairCormatrix Cardiovascular, Inc.200711—
+3K152127CorMatrix TykeCormatrix Cardiovascular, Inc.20162—
+3K140306Cormatrix Protect Ecm EnvelopeCormatrix Cardiovascular, Inc.201442
+3K140789Cormatrix Ecm for Vascular RepairCormatrix Cardiovascular, Inc.20140—
+3K111187Patch, Pledget and IntracardiacCormatrix Cardiovascular, Inc.20111—
+3K081438Matracell Decellularized Pulmonary Artery Patch AllograftLifenet Health20080—
+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
+5K182255CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro…Aziyo Biologics, Inc.201821
+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—