The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Baxter Arena Hemodialysis Delivery System, Model 1571278000.
| Device ID | K030099 |
| 510k Number | K030099 |
| Device Name: | BAXTER ARENA HEMODIALYSIS DELIVERY SYSTEM, MODEL 1571278000 |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | BAXTER HEALTHCARE CORP. 1620 WAUKEGAN RD., MPR-A2E Mcgaw Park, IL 60085 -6730 |
| Contact | Robert L Wilkinson |
| Correspondent | Mark Job TUV AMERICA, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-01-10 |
| Decision Date | 2003-06-17 |