510(k) Report

Devices descending from K964467

16 later devices reach Shelhigh Pericardial Patch through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K981756Shelhigh NO-React PneumopledgetsShelhigh, Inc.19981—
+1K974914Shelhigh NO-React Pericardial PatchesShelhigh, Inc.199815—
+2K991567Shelhigh NO-React Tissue Repair Patch/Uropatch.Shelhigh, Inc.19990—
+2K982810Shelhigh NO-React VascupatchShelhigh, Inc.199812—
+3K063349Cormatrix Patch for Cardiac Tissue RepairCormatrix Cardiovascular, Inc.200711—
+4K152127CorMatrix TykeCormatrix Cardiovascular, Inc.20162—
+4K140306Cormatrix Protect Ecm EnvelopeCormatrix Cardiovascular, Inc.201442
+4K140789Cormatrix Ecm for Vascular RepairCormatrix Cardiovascular, Inc.20140—
+4K111187Patch, Pledget and IntracardiacCormatrix Cardiovascular, Inc.20111—
+4K081438Matracell Decellularized Pulmonary Artery Patch AllograftLifenet Health20080—
+5K181038CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single…Cormatrix Cardiovascular, Inc.20181—
+5K173242CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.201731
+6K210331CardiaMend Pericardial and Epicardial Reconstruction MatrixHelios Cardio, Inc.20210—
+6K182255CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro…Aziyo Biologics, Inc.201821
+7K192616CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.20191—
+8K201313CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.20200—