The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Baxter Reinforced Expanded Ptfe Vascular Graft.
| Device ID | K933590 |
| 510k Number | K933590 |
| Device Name: | BAXTER REINFORCED EXPANDED PTFE VASCULAR GRAFT |
| Classification | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| Applicant | BAXTER HEALTHCARE CORP. EWARDS CVS DIVISION P.O. BOX 11150 Santa Ana, CA 92711 -1150 |
| Contact | Roberta Hines |
| Correspondent | Roberta Hines BAXTER HEALTHCARE CORP. EWARDS CVS DIVISION P.O. BOX 11150 Santa Ana, CA 92711 -1150 |
| Product Code | DSY |
| CFR Regulation Number | 870.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-26 |
| Decision Date | 1994-01-26 |