510(k) K041726 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
HIGH FLUX HEMODIALYSIS MEMBRANE DIALYZER OR HIGH FLUX HOLLOW FIBER DIALYZER, MODELS APS-R, -M, -S, -E, AND -EX
| Applicant | Asahi Medical Co., Ltd., Rockville MD, US |
| Decision | Substantially Equivalent, Jul 23, 2004 |
| Received | Jun 25, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K041726
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 14, 2006 | Asahi Medical Co., Ltd Asahi APS Series Multiple-Use Hollow Fiber Dialyzers; a wet model multiple use dialyzer consisting of hollow fiber membranes of polysulfone housed within a plastic casing of styrene butadiene block po Terminated |
KDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.