The following data is part of a premarket notification filed by Baxter Healthcare Corporation with the FDA for Prismaflex St60 Set, Prismaflex St100 Set, Prismaflex St150 Set.
| Device ID | K212216 |
| 510k Number | K212216 |
| Device Name: | Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 Set |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | Baxter Healthcare Corporation One Baxter Parkway Deerfield, IL 60015 |
| Contact | Fortunato (tito) Aldape |
| Correspondent | Maud Humbert Gambro Industries 7 Avenue Lionel Terray B.P 126 Meyzieu, FR F-69883 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-16 |
| Decision Date | 2022-04-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50085412954108 | K212216 | 000 |
| 50085412954078 | K212216 | 000 |
| 50085412917691 | K212216 | 000 |