510(k) K060195 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
GAMBRO POLYFLUX HD-C4 CAPILLARY DIALYZER/FILTER FOR SINGLE USE
| Applicant | Gambro Renal Products, Lakewood CO, US |
| Decision | Substantially Equivalent, Apr 24, 2006 |
| Received | Jan 25, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060195
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 8, 2016 | Baxter Healthcare Corp. GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE, Product code 110634
Product Usage:
The Revaclear Max dialyzer is a single use device used for treatment of chronic and acute renal fail Terminated |
KDL | None listed |
| May 21, 2014 | Gambro Renal Products, Incorporated Polyflux Revaclear Max, Capillary Dialyzer, Model Number 110634;
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.