K140306 is an FDA 510(k) clearance for the CORMATRIX PROTECT ECM ENVELOPE. This device is classified as a Mesh, Surgical (Class II - Special Controls, product code FTM).
Submitted by Cormatrix Cardiovascular, Inc. (Roswell, US). The FDA issued a Cleared decision on August 15, 2014, 189 days after receiving the submission on February 7, 2014.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3300.
| 510(k) Number | K140306 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 07, 2014 |
| Decision Date | August 15, 2014 |
| Days to Decision | 189 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FTM — Mesh, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3300 |