The following data is part of a premarket notification filed by Baxter Healthcare Corp with the FDA for Prismax System Version 2.
| Device ID | K190910 |
| 510k Number | K190910 |
| Device Name: | PrisMax System Version 2 |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | Baxter Healthcare Corp 7601 Northland Drive Suite 170 Brooklyn Park, MN 55428 |
| Contact | Chris Scavotto |
| Correspondent | Chris Scavotto Baxter Healthcare Corp 7601 Northland Drive Suite 170 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 | 2019-04-08 |
| Decision Date | 2019-07-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 37332414123933 | K190910 | 000 |
| 00085412639505 | K190910 | 000 |
| 00085412639499 | K190910 | 000 |