# Cormatrix Cardiovascular, Inc.

- Location (FDA's records): Roswell, GA
- FDA decisions: 7 (2005–2018): 7 510(k) clearances
- Product codes: DXZ (5), FTM (1), PSQ (1)
- Predicates its devices cite: 28 (7 its own); citations of its devices by later devices: 14 (7 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Cook Biotech, Inc.: 8 (https://510kreport.com/company/cook-biotech)
- Bio-Vascular, Inc.: 3 (https://510kreport.com/company/bio-vascular)
- Vascutek, Ltd.: 1 (https://510kreport.com/company/vascutek)
- Tei Biosciences, Inc.: 1 (https://510kreport.com/company/tei-biosciences)
- W. L. Gore & Associates, Inc.: 1 (https://510kreport.com/company/w-l-gore-associates)
- Pm Devices, Inc.: 1 (https://510kreport.com/company/pm-devices)
- Peritec Biosciences, LLC: 1 (https://510kreport.com/company/peritec-biosciences)
- Shelhigh, Inc.: 1 (https://510kreport.com/company/shelhigh)

## Firms that cite its devices most
- Helios Cardio, Inc.: 2 (https://510kreport.com/company/helios-cardio)
- Lifenet Health: 1 (https://510kreport.com/company/lifenet-health)
- Acell, Inc.: 1 (https://510kreport.com/company/acell)
- Aziyo Biologics, Inc.: 1 (https://510kreport.com/company/aziyo-biologics)
- Mast Biosurgery USA, Inc.: 1 (https://510kreport.com/company/mast-biosurgery-usa)
- Synovis Surgical Innovations: 1 (https://510kreport.com/company/synovis-surgical-innovations)

## Its most-cited devices
- K051405: Regensis Pericardial Patch (2005), cited by 5
- K063349: Cormatrix Patch for Cardiac Tissue Repair (2007), cited by 5
- K111187: Patch, Pledget and Intracardiac (2011), cited by 1
- K152127: CorMatrix Tyke (2016), cited by 1
- K140306: Cormatrix Protect Ecm Envelope (2014), cited by 1
- K181038: CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single pack), CorMatrix Cor Patch (7 cm x 10 cm)(single pack) (2018), cited by 1

## Recent decisions
- K181038: CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single pack), CorMatrix Cor Patch (7 cm x 10 cm)(single pack) (Oct 10, 2018)
- K152127: CorMatrix Tyke (Feb 4, 2016)
- K140306: Cormatrix Protect Ecm Envelope (Aug 15, 2014)
- K140789: Cormatrix Ecm for Vascular Repair (Jul 15, 2014)
- K111187: Patch, Pledget and Intracardiac (Jul 26, 2011)
- K063349: Cormatrix Patch for Cardiac Tissue Repair (Feb 16, 2007)
- K051405: Regensis Pericardial Patch (Aug 31, 2005)

Source page: https://510kreport.com/company/cormatrix-cardiovascular