The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Transluminal Endarterectomy Device.
| Device ID | K904944 |
| 510k Number | K904944 |
| Device Name: | TRANSLUMINAL ENDARTERECTOMY DEVICE |
| Classification | Stripper, Artery, Intraluminal |
| Applicant | BAXTER HEALTHCARE CORP. P.O. BOX 11150 Santa Ana, CA 92711 |
| Contact | Ronald H Bergeson |
| Correspondent | Ronald H Bergeson BAXTER HEALTHCARE CORP. P.O. BOX 11150 Santa Ana, CA 92711 |
| Product Code | DWX |
| CFR Regulation Number | 870.4875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-01 |
| Decision Date | 1990-12-17 |