The following data is part of a premarket notification filed by Baxter Healthcare Corporation with the FDA for Prismax System Version 3.
| Device ID | K193482 |
| 510k Number | K193482 |
| Device Name: | PrisMax System Version 3 |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | Baxter Healthcare Corporation 7601 Northland Drive Brooklyn Park, MN 55428 |
| Contact | Christopher Scavotto |
| Correspondent | Christopher Scavotto Baxter Healthcare Corporation 7601 Northland Drive Brooklyn Park, MN 55428 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-17 |
| Decision Date | 2020-03-13 |