510(k) K001250 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
APS SERIES DIALYZERS (WET MODELS), APS SERIES DIALYSIS (DRY MODELS)
| Applicant | Asahi Medical Co., Ltd., Rockville MD, US |
| Decision | Substantially Equivalent, Aug 16, 2000 |
| Received | Apr 19, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001250
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 3, 2005 | Asahi Medical Co Ltd Asahi APS Series Hollow Fiber Dialyzers; a wet model mutiple use dialyzer consisting of hollow fiber membranes of polysulfone housed within a plastic casing of styrene butadiene block polymer, filled Terminated |
KDI | None listed |
| Jul 20, 2004 | Asahi Medical Co Ltd Asahi APS Series Dialyzers, Model Nos. APS-400S, APS-550S, APS-650S, APS-750S, APS-900S, APS-1050S; the dialyzers are intended for single or initial use and under reprocessing and reuse conditions fo Terminated |
KDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.