K082139 is an FDA 510(k) clearance for the EDWARDS BOVINE PERICARDIAL PATCH, MODEL 4700. This device is classified as a Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene (Class II - Special Controls, product code DXZ).
Submitted by Edwards Lifesciences, LLC (Irvine, US). The FDA issued a Cleared decision on October 23, 2008, 86 days after receiving the submission on July 29, 2008.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3470.
| 510(k) Number | K082139 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 29, 2008 |
| Decision Date | October 23, 2008 |
| Days to Decision | 86 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 |