510(k) K082515 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
ASAHI REXEED-SX/LX DIALYZERS, MODELS: 13SX, 15SX, 18SX, 21SX, 25SX, 13LX, 15LX, 18LX, 21LX
| Applicant | Asahi Kasei Medical Co., Ltd., Rockville MD, US |
| Decision | Substantially Equivalent, Oct 3, 2008 |
| Received | Sep 2, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K082515
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 20, 2012 | Asahi Kasei Medical Co., Ltd., Okatomi Plant Asahi KASEI, REXEED(TM)- 15 SX, HEMODIALYZER
dialysis filter Terminated |
KDI | None listed |
| Sep 20, 2012 | Asahi Kasei Medical Co., Ltd., Okatomi Plant Asahi KASEI, REXEED(TM)- 18 SX, HEMODIALYZER
dialysis filter Terminated |
KDI | None listed |
| Sep 20, 2012 | Asahi Kasei Medical Co., Ltd., Okatomi Plant Asahi KASEI, REXEED(TM)- 21 SX, HEMODIALYZER
dialysis filter Terminated |
KDI | None listed |
| Sep 20, 2012 | Asahi Kasei Medical Co., Ltd., Okatomi Plant Asahi KASEI, REXEED(TM)- 25 SX, HEMODIALYZER
dialysis filter Terminated |
KDI | None listed |
| Sep 20, 2012 | Asahi Kasei Medical Co., Ltd., Okatomi Plant Asahi KASEI, REXEED(TM)- 13 LX, HEMODIALYZER
dialysis filter Terminated |
KDI | None listed |
| Sep 20, 2012 | Asahi Kasei Medical Co., Ltd., Okatomi Plant Asahi KASEI, REXEED(TM)- 15 LX, HEMODIALYZER
dialysis filter Terminated |
KDI | None listed |
| Sep 20, 2012 | Asahi Kasei Medical Co., Ltd., Okatomi Plant Asahi KASEI, REXEED(TM)- 18 LX, HEMODIALYZER
dialysis filter Terminated |
KDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.