510(k) K032431 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
PRISMA M60/M100 SETS
| Applicant | Gambro, Inc., Lakewood CO, US |
| Decision | Substantially Equivalent, Sep 15, 2003 |
| Received | Aug 6, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K032431
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 13, 2014 | Gambro Renal Products, Incorporated Prisma M 60 PRE set (new design). Product number 103658. Each set is packaged in a plastic pouch, 4 pouches per carton box Terminated |
KDI | None listed |
| Aug 13, 2014 | Gambro Renal Products, Incorporated Prisma M60 POSTDILUTION set. Product number 104183. Each set is packaged in a plastic pouch, 4 pouches per carton box Terminated |
KDI | None listed |
| Aug 13, 2014 | Gambro Renal Products, Incorporated Prisma M 100 PRE set. Product number 103657. Each set is packaged in a plastic pouch, 4 pouches per carton box Terminated |
KDI | None listed |
| Aug 13, 2014 | Gambro Renal Products, Incorporated Prisma M100 set. Product number 104182. Each set is packaged in a plastic pouch, 4 pouches per carton box Terminated |
KDI | None listed |
| Aug 13, 2014 | Gambro Renal Products, Incorporated Prisma M100 PRE pump infusion set. Product number 107791. 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 M100 preset, Part No. 8353486. Terminated |
KDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.