The following data is part of a premarket notification filed by Baxter Edwards with the FDA for Baxter Eptfe Externally Supported Vascular Grafts.
| Device ID | K944858 |
| 510k Number | K944858 |
| Device Name: | BAXTER EPTFE EXTERNALLY SUPPORTED VASCULAR GRAFTS |
| Classification | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| Applicant | BAXTER EDWARDS 17221 RED HILL AVE. Irvine, CA 92614 -5627 |
| Contact | Esther Saltz |
| Correspondent | Esther Saltz BAXTER EDWARDS 17221 RED HILL AVE. Irvine, CA 92614 -5627 |
| Product Code | DSY |
| CFR Regulation Number | 870.3450 [🔎] |
| Decision | Se Subject To Tracking Reg (ST) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-03 |
| Decision Date | 1995-01-05 |