MatriStem UBM Pericardial Patch
FDA 510(k)Class II (US FDA 510(k))
by Acell, Inc.
Identifiers
- 510(k) Number
- K191734 FDA 510(k)
- FDA Product Code
- PSQ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.3470 FDA 510(k)
- Regulation Number
- 870.3470 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The MatriStem UBM Pericardial Patch is a biologically derived intracardiac patch designed for the reconstruction and repair of the pericardium. Classified as a Class II device under product code PSQ, it is intended for use in cardiovascular applications, providing structural support to damaged or deficient pericardial tissue.
This device is supplied sterile and intended for single-use. It is regulated under FDA 510(k) clearance (K191734) with a decision of Substantially Equivalent, reviewed by the Cardiovascular (CV) Advisory Committee. The patch is manufactured by ACell, Inc. and adheres to regulatory standards outlined in 870.3470, ensuring compliance for surgical use in pericardial repair procedures.
Frequently asked questions
What is the MatriStem UBM Pericardial Patch primarily used for in clinical settings?
The MatriStem UBM Pericardial Patch is designed for reconstructing and repairing damaged or deficient pericardial tissue, providing structural support in cardiovascular applications. It is specifically intended for intracardiac use, helping to restore function in areas where the pericardium has been compromised.
Is the MatriStem UBM Pericardial Patch intended for reuse, or is it meant to be used only once?
The MatriStem UBM Pericardial Patch is explicitly supplied sterile and intended for single-use only. This ensures patient safety and maintains the device’s integrity for one surgical procedure.
How is the MatriStem UBM Pericardial Patch regulated by the FDA, and what does that mean for its use?
The MatriStem UBM Pericardial Patch is classified as a Class II device under product code PSQ and has received FDA 510(k) clearance (K191734) with a decision of *Substantially Equivalent*. This means it has been reviewed by the Cardiovascular (CV) Advisory Committee and deemed comparable to a legally marketed predicate device, ensuring it meets regulatory standards for surgical pericardial repair.
What sizes or models of the MatriStem UBM Pericardial Patch are available, and how are they identified?
The MatriStem UBM Pericardial Patch is available in multiple sizes, as indicated by the FEI numbers (e.g., 3012664855, 1047843, etc.) listed in the regulatory records. These identifiers correspond to different patch dimensions tailored for specific surgical needs. For exact sizing details, refer to the manufacturer’s packaging or technical documentation.
How should the MatriStem UBM Pericardial Patch be stored before use?
While the provided data does not specify storage conditions explicitly, as a sterile, single-use surgical device, it should be stored in a clean, dry environment protected from moisture, extreme temperatures, and contamination. Always follow the manufacturer’s instructions (ACell, Inc.) for optimal shelf life and sterility preservation.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: MatriStem UBM Pericardial Patch (K191734) — FDA 510 (k) | Innolitics, K191734 FDA 510 (k) - MatriStem UBM Pericardial Patch, K191734 - MatriStem UBM Pericardial Patch FDA 510 (k) APPLICATION FOR ..., MatriStem UBM Pericardial Patch - FDA 510(k) K191734, PDF Michelle Huettner Director of Regulatory Affairs 6640 Eli Whitney Drive ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K191734 | Class II | Active |
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Manufacturer
- Manufacturer
- Acell, Inc.
Sources (1)
- FDA 510(k) K191734 24 fields · synced Sep 19, 2026