CorMatrix Patch, Pledget, and Intracardiac
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K111187 FDA 510(k)
- FDA Product Code
- DXZ 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 CorMatrix Patch, Pledget, and Intracardiac is a Class II intracardiac patch or pledget device, constructed from materials such as polypropylene, polyethylene terephthalate (PETP), or polytetrafluoroethylene (PTFE). It is designed to repair cardiac tissue defects, including atrial septal defects (ASD) and ventricular septal defects (VSD), as well as to reinforce suture lines during cardiac procedures.
These devices are intended for single-use in cardiac surgery settings and are supplied sterile. They are regulated under 21 CFR 870.3470 and have received FDA 510(k) clearance (K111187) as substantially equivalent to the predicate device. Multiple product codes (e.g., 2183620, 1526611) identify variations in size and material composition, ensuring compatibility with specific surgical applications.
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: PATCH, PLEDGET AND INTRACARDIAC (K111187) — FDA 510 (k) | Innolitics, PDF CORMATRIX CARDIOVASCULAR, INC. PREMARKET NOTIFICATION 5 10(k) SUMMARY ..., PDF Inc. Ecm11 for Carotid Repair Jul 2 20115 5ju 2621
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K111187 | Class II | Active |
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Manufacturer
- Manufacturer
- Cormatrix Cardiovascular, Inc.
Sources (1)
- FDA 510(k) K111187 24 fields · synced Sep 19, 2026