K181038 is an FDA 510(k) clearance for the 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). This device is classified as a Intracardiac Patch Or Pledget, Biologically Derived (Class II - Special Controls, product code PSQ).
Submitted by Cormatrix Cardiovascular, Inc. (Roswell, US). The FDA issued a Cleared decision on October 10, 2018, 174 days after receiving the submission on April 19, 2018.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3470. To Repair Defects, To Be Used For Patch Grafting, To Repair Tissue, And To Buttress Sutures In The Heart And Vasculature..
| 510(k) Number | K181038 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 19, 2018 |
| Decision Date | October 10, 2018 |
| Days to Decision | 174 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | PSQ — Intracardiac Patch Or Pledget, Biologically Derived |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3470 |
| Definition | To Repair Defects, To Be Used For Patch Grafting, To Repair Tissue, And To Buttress Sutures In The Heart And Vasculature. |