510(k) K013418 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
AM-BIO EXTENDED RANGE SERIES DIALYZER, MODELS WET AND DRY
| Applicant | Asahi Medical Co., Ltd., Rockville MD, US |
| Decision | Substantially Equivalent, Jul 9, 2002 |
| Received | Oct 15, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013418
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 3, 2005 | Asahi Medical Co Ltd Asahi AM-BIO-HX Extended Range Series Hollow Fiber Dialyzers; a wet model single use dialyzer consisting of hollow fiber membranes of alkyl ether polymer grafted cellulose housed within a plastic casi Terminated |
KDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.