The following data is part of a premarket notification filed by Baxter Healthcare Corporation with the FDA for Prismaflex System 8.10.
| Device ID | K171671 |
| 510k Number | K171671 |
| Device Name: | Prismaflex System 8.10 |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | Baxter Healthcare Corporation 32650 North Wilson Road Round Lake, IL 60073 |
| Contact | Rick Lukacovic |
| Correspondent | Rick Lukacovic Baxter Healthcare Corporation 32650 North Wilson Road Round Lake, IL 60073 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-06 |
| Decision Date | 2018-02-23 |
| Summary: | summary |