The following data is part of a premarket notification filed by Med-west, Inc. with the FDA for Acute Hemodialysis Tray, Cat.#09-9540-7.
| Device ID | K854612 |
| 510k Number | K854612 |
| Device Name: | ACUTE HEMODIALYSIS TRAY, CAT.#09-9540-7 |
| Classification | Catheter, Femoral |
| Applicant | MED-WEST, INC. P.O. BOX 26851 Salt Lake City, UT 84126 |
| Contact | Dave Beattie |
| Correspondent | Dave Beattie MED-WEST, INC. P.O. BOX 26851 Salt Lake City, UT 84126 |
| Product Code | LFK |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent - With Drug (SESD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-18 |
| Decision Date | 1986-01-03 |