510(k) K193482 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
PrisMax System Version 3
| Applicant | Baxter Healthcare Corporation, Brooklyn Park MN, US |
| Decision | Substantially Equivalent, Mar 13, 2020 |
| Received | Dec 17, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193482
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 26, 2025 | VANTIVE US HEALTHCARE LLC PrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724 Open, Classified |
KDI | None listed |
| Aug 26, 2025 | VANTIVE US HEALTHCARE LLC TherMax Blood Warmer Unit-US, PrisMax Accessory, Product Codes: 955630, 955515, 955702, 955631 Open, Classified |
KDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.