The following data is part of a premarket notification filed by Baxter Healthcare Corporation - Renal Division with the FDA for Xenium Xpm 110, Xenium Xpm 130, Models M25649a, M25650a, Xenium Xpm 150, Xenium Xpm 170.
| Device ID | K093120 |
| 510k Number | K093120 |
| Device Name: | XENIUM XPM 110, XENIUM XPM 130, MODELS M25649A, M25650A, XENIUM XPM 150, XENIUM XPM 170 |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | BAXTER HEALTHCARE CORPORATION - RENAL DIVISION 1620 WAUKEGAN ROAD BUILDING R Mcgaw Park, IL 60085 |
| Contact | Diane Rennpferd |
| Correspondent | Diane Rennpferd BAXTER HEALTHCARE CORPORATION - RENAL DIVISION 1620 WAUKEGAN ROAD BUILDING R Mcgaw Park, IL 60085 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-02 |
| Decision Date | 2010-02-17 |
| Summary: | summary |