The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Baxter Reinforced Expanded Ptfe Stepped Vascular Graft.
| Device ID | K944844 |
| 510k Number | K944844 |
| Device Name: | BAXTER REINFORCED EXPANDED PTFE STEPPED VASCULAR GRAFT |
| Classification | Prosthesis, Vascular Graft, Of Less Then 6mm Diameter |
| Applicant | BAXTER HEALTHCARE CORP. 17221 RED HILL AVE. Irvine, CA 92714 |
| Contact | Esther Saltz |
| Correspondent | Esther Saltz BAXTER HEALTHCARE CORP. 17221 RED HILL AVE. Irvine, CA 92714 |
| Product Code | DYF |
| CFR Regulation Number | 870.3450 [🔎] |
| Decision | Se - Postmarket Surveillance Required (SESP) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-30 |
| Decision Date | 1995-03-31 |