MatriStem UBM Pericardial Patch
FDA 510(k) K191734 · Acell, Inc.
510(k) numberK191734
Submission
- Device name
- MatriStem UBM Pericardial Patch
- Applicant
- Acell, Inc.
Columbia, MD, US - Received
- June 28, 2019
- Decision date
- November 22, 2019
- 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.
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| 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 |
| K183635 | PhotoFix Decellularized Bovine PericardiumPSQ · Special | Cryolife, Inc. | 02/14/2019SE |
| K181038 | CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single…PSQ · Traditional | Cormatrix Cardiovascular, Inc. | 10/10/2018SE |
| 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.
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|---|---|---|
| K241724 | Cytal® Wound Matrix; Cytal® Burn MatrixKGN · Special | 07/11/2024SE |
| K241706 | MicroMatrix® UBM ParticulateKGN · Special | 07/11/2024SE |
| K230980 | MicroMatrix® FlexKGN · Traditional | 09/22/2023SE |
| K192725 | Cytal Wound Matrix 3-LayerKGN · Special | 10/25/2019SE |
| K182259 | Gentrix Surgical Matrix, Gentrix Surgical Matrix HiatalFTM · Traditional | 02/07/2019SE |
| K180776 | Cytal Wound ParticulateKGN · Special | 05/11/2018SE |
| K172399 | MicroMatrixKGN · Traditional | 10/06/2017SE |
| K170763 | Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix ExtendFTM · Traditional | 06/08/2017SE |
| K162554 | Gentrix Surgical MatrixFTM · Special | 10/21/2016SE |
| K153754 | MicroMatrixKGN · Special | 03/14/2016SE |
Questions and answers
When was MatriStem UBM Pericardial Patch cleared by the FDA?
MatriStem UBM Pericardial Patch (K191734) received a 510(k) decision of Substantially Equivalent on November 22, 2019, 147 days after the submission was received.
What is the product code of K191734?
The FDA product code is PSQ – Intracardiac Patch Or Pledget, Biologically Derived, a Class II (moderate risk) device regulated under 21 CFR 870.3470.