The following data is part of a premarket notification filed by Baxter Edwards with the FDA for Fogarty Valvulotome Model 700091.
| Device ID | K965137 |
| 510k Number | K965137 |
| Device Name: | FOGARTY VALVULOTOME MODEL 700091 |
| Classification | Valvulotome |
| Applicant | BAXTER EDWARDS 17221 RED HILL AVE. Irvine, CA 92614 -5627 |
| Contact | Paula Torrianni |
| Correspondent | Paula Torrianni BAXTER EDWARDS 17221 RED HILL AVE. Irvine, CA 92614 -5627 |
| Product Code | MGZ |
| CFR Regulation Number | 870.4885 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-23 |
| Decision Date | 1997-06-04 |
| Summary: | summary |