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)
FDA 510(k) K181038 · Cormatrix Cardiovascular, Inc.
510(k) numberK181038
Submission
- Device name
- 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)
- Applicant
- Cormatrix Cardiovascular, Inc.
Roswell, GA, US - Received
- April 19, 2018
- Decision date
- October 10, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PSQ – Intracardiac Patch Or Pledget, Biologically Derived
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3470
- Specialty
- Cardiovascular
- Implant
- Yes
To repair defects, to be used for patch grafting, to repair tissue, and to buttress sutures in the heart and vasculature.
Other 510(k)s with product code PSQ
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|---|---|---|---|
| K221032 | Vascu-Guard Vascular Repair PatchPSQ · Traditional | Synovis Life Technologies, Inc. | 10/19/2022SE |
| K221029 | PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair PatchPSQ · Traditional | Synovis Life Technologies, Inc. | 10/19/2022SE |
| K210331 | CardiaMend Pericardial and Epicardial Reconstruction MatrixPSQ · Traditional | Helios Cardio, Inc. | 12/21/2021SE |
| K200566 | ADAPT TissuePSQ · Special | Admedus Regen Pty, Ltd. | 04/03/2020SE |
| K190882 | XenoSure Biologic PatchPSQ · Traditional | Lemaitre Vascular | 02/13/2020SE |
| K191734 | MatriStem UBM Pericardial PatchPSQ · Traditional | Acell, Inc. | 11/22/2019SE |
| K183635 | PhotoFix Decellularized Bovine PericardiumPSQ · Special | Cryolife, Inc. | 02/14/2019SE |
| K172085 | PhotoFix Decellularized Bovine PericardiumPSQ · Traditional | Cryolife, Inc. | 12/04/2017SE |
| K172660 | Duravess bovine pericardial vascular patchPSQ · Traditional | Edwards Lifesciences, LLC | 11/17/2017SE |
| K170951 | CardioCel 3DPSQ · Special | Admedus Regen Pty, Ltd. | 04/28/2017SE |
More from Admedus Regen Pty, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K152127 | CorMatrix TykeDXZ · Traditional | 02/04/2016SE |
| K140306 | Cormatrix Protect Ecm EnvelopeFTM · Traditional | 08/15/2014SE |
| K140789 | Cormatrix Ecm for Vascular RepairDXZ · Traditional | 07/15/2014SE |
| K111187 | Patch, Pledget and IntracardiacDXZ · Traditional | 07/26/2011SE |
| K063349 | Cormatrix Patch for Cardiac Tissue RepairDXZ · Traditional | 02/16/2007SE |
| K051405 | Regensis Pericardial PatchDXZ · Traditional | 08/31/2005SE |
Questions and answers
When was 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) cleared by the FDA?
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) (K181038) received a 510(k) decision of Substantially Equivalent on October 10, 2018, 174 days after the submission was received.
What is the product code of K181038?
The FDA product code is PSQ – Intracardiac Patch Or Pledget, Biologically Derived, a Class II (moderate risk) device regulated under 21 CFR 870.3470.