510(k) Report

Devices descending from K063349

11 later devices reach Cormatrix Patch for Cardiac Tissue Repair through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152127CorMatrix TykeCormatrix Cardiovascular, Inc.20162—
+1K140306Cormatrix Protect Ecm EnvelopeCormatrix Cardiovascular, Inc.201442
+1K140789Cormatrix Ecm for Vascular RepairCormatrix Cardiovascular, Inc.20140—
+1K111187Patch, Pledget and IntracardiacCormatrix Cardiovascular, Inc.20111—
+1K081438Matracell Decellularized Pulmonary Artery Patch AllograftLifenet Health20080—
+2K181038CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single…Cormatrix Cardiovascular, Inc.20181—
+2K173242CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.201731
+3K210331CardiaMend Pericardial and Epicardial Reconstruction MatrixHelios Cardio, Inc.20210—
+3K182255CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro…Aziyo Biologics, Inc.201821
+4K192616CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.20191—
+5K201313CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.20200—