510(k) Report

Devices descending from K982810

12 later devices reach Shelhigh NO-React Vascupatch through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K063349Cormatrix Patch for Cardiac Tissue RepairCormatrix Cardiovascular, Inc.200711—
+2K152127CorMatrix TykeCormatrix Cardiovascular, Inc.20162—
+2K140306Cormatrix Protect Ecm EnvelopeCormatrix Cardiovascular, Inc.201442
+2K140789Cormatrix Ecm for Vascular RepairCormatrix Cardiovascular, Inc.20140—
+2K111187Patch, Pledget and IntracardiacCormatrix Cardiovascular, Inc.20111—
+2K081438Matracell Decellularized Pulmonary Artery Patch AllograftLifenet Health20080—
+3K181038CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single…Cormatrix Cardiovascular, Inc.20181—
+3K173242CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.201731
+4K210331CardiaMend Pericardial and Epicardial Reconstruction MatrixHelios Cardio, Inc.20210—
+4K182255CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro…Aziyo Biologics, Inc.201821
+5K192616CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.20191—
+6K201313CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc.20200—