The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Edwards-duromedics Mitral Valve Rotator.
| Device ID | K880052 |
| 510k Number | K880052 |
| Device Name: | EDWARDS-DUROMEDICS MITRAL VALVE ROTATOR |
| Classification | Holder, Heart-valve, Prosthesis |
| Applicant | BAXTER HEALTHCARE CORP. P.O. BOX 11150 Santa Ana, CA 92711 |
| Contact | John L Ely |
| Correspondent | John L Ely BAXTER HEALTHCARE CORP. P.O. BOX 11150 Santa Ana, CA 92711 |
| Product Code | DTJ |
| CFR Regulation Number | 870.3935 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-06 |
| Decision Date | 1988-04-01 |