510(k) K051187 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
REXEED SERIES DIALYZERS
| Applicant | Asahi Kasei Medical Co., Ltd., Rockville MD, US |
| Decision | Substantially Equivalent, Jun 8, 2005 |
| Received | May 9, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K051187
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 14, 2006 | Asahi Medical Co., Ltd Asahi Rexeed Series Multiple-Use Hollow Fiber Dialyzers; a wet model multiple use dialyzer consisting of hollow fiber membranes of polysulfone/PVP housed within a plastic casing of styrene copolymer, Terminated |
KDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.