The following data is part of a premarket notification filed by American Edwards Laboratories with the FDA for Pericardial Patch.
| Device ID | K833763 |
| 510k Number | K833763 |
| Device Name: | PERICARDIAL PATCH |
| Classification | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene |
| Applicant | AMERICAN EDWARDS LABORATORIES 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DXZ |
| CFR Regulation Number | 870.3470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-10-26 |
| Decision Date | 1984-11-01 |