The following data is part of a premarket notification filed by Edwards Lifesciences, Llc. with the FDA for Edwards Bovine Pericardial Patch, Model 4700.
| Device ID | K082139 |
| 510k Number | K082139 |
| Device Name: | EDWARDS BOVINE PERICARDIAL PATCH, MODEL 4700 |
| Classification | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene |
| Applicant | EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY Irvine, CA 92614 |
| Contact | Daryl Richardson |
| Correspondent | Daryl Richardson EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY Irvine, CA 92614 |
| Product Code | DXZ |
| CFR Regulation Number | 870.3470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-29 |
| Decision Date | 2008-10-23 |
| Summary: | summary |