510(k) K001156 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
PHOENIX HEMODIALYSIS DELIVERY SYSTEM, GAMBRO CARTRIDGE FOR HEMODIALYSIS BLOOD TUBING SET
| Applicant | Gambro Renal Products, Lakewood CO, US |
| Decision | Substantially Equivalent, Jul 7, 2000 |
| Received | Apr 10, 2000 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K001156
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 25, 2008 | Gambro Renal Products, Inc. Gambro cartridge blood tubing set used with Gambro Dasco Phoenix and Cobe Centrysystem 3 (and 3+) Hemodialysis System, Gambro, Lakewood, CO 80401 Terminated |
KDI | None listed |
| Nov 21, 2006 | Gambro Renal Products, Inc. Gambro Phoenix Hemodialysis Machine, Model numbers: 6022933700, 6023006700, 6022966700, Gambro Dasco S.p.A., Italy. Terminated |
KDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.