K063349 is an FDA 510(k) clearance for the CORMATRIX PATCH FOR CARDIAC TISSUE REPAIR. This device is classified as a Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene (Class II - Special Controls, product code DXZ).
Submitted by Cormatrix Cardiovascular, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on February 16, 2007, 102 days after receiving the submission on November 6, 2006.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3470.
| 510(k) Number | K063349 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 06, 2006 |
| Decision Date | February 16, 2007 |
| Days to Decision | 102 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXZ — Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3470 |