510(k) K232467 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
CleanCart A, CleanCart C, AK 98 Hemodialysis Machine
| Applicant | Baxter Healthcare Corporation, Round Lake IL, US |
| Decision | Substantially Equivalent, Sep 14, 2023 |
| Received | Aug 15, 2023 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K232467
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 13, 2024 | Baxter Healthcare Corporation Baxter AK 98 Dialysis Machine, Hemodialysis Delivery System, Product Code 955607. As of February 2025, the firm name is Vantive. Open, Classified |
KDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.