CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 c…
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K181038 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 device is an intracardiac patch or pledget, biologically derived, intended for epicardial tissue support and repair. It is a 4-ply, lyophilized, sterilized sheet of porcine small intestinal submucosa extracellular matrix (SIS-ECM).
It is used by surgeons for epicardial tissue support and repair, acting as a scaffold for tissue reinforcement. The device is provided in various sizes, including 3 cm x 5 cm, 4 cm x 7 cm, and 7 cm x 10 cm, each supplied as a single pack. It has received FDA 510(k) clearance under K181038 with product code PSQ and is classified as a Class II device under regulation 870.3470.
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: CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 ..., K181038 FDA 510(k) - CorMatrix Cor Patch (3 cm x 5 cm)(singl..., CorMatrix Cor Patch (3 Cm X 5 Cm)(single Pack)… - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K181038 | Class II | Active |
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Manufacturer
- Manufacturer
- Cormatrix Cardiovascular, Inc.
Sources (1)
- FDA 510(k) K181038 24 fields · synced Sep 25, 2026