510(k) K011221 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
PRISMA HF 1000 SET, PRISMA HF 1000 PRE-SET
| Applicant | Gambro Renal Products, Lakewood CO, US |
| Decision | Substantially Equivalent, Oct 31, 2001 |
| Received | Apr 20, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011221
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 13, 2014 | Gambro Renal Products, Incorporated Prisma HF1000 preset (new design). Product number 107639. Each set is packaged in a plastic pouch, 4 pouches per carton box Terminated |
KDI | None listed |
| Apr 5, 2006 | Gambro Renal Products, Inc. Gambro Prisma HF1000 preset, Part No. 8399050. Terminated |
KDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.