510(k) K072232 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
GAMBRO POLYFLUX HEMODIALYZER, MODEL: HD-C4 SMALL
| Applicant | Gambro Renal Products, Inc., Lakewood CO, US |
| Decision | Substantially Equivalent, Sep 7, 2007 |
| Received | Aug 10, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K072232
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 21, 2014 | Gambro Renal Products, Incorporated Polyflux Revaclear, Capillary Dialyzer, Model Number 110633;
Gambro Renal Products, Inc.
Intended for the treatment of acute and chronic renal failure by hemodialysis. Terminated |
KDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.