510(k) K983720 ยท MSE Hemodialyzer, Re-Use, Low Flux
ASAHI AM-BIO SERIES DIALYZERS (WET MODELS)& (DRY MODELS), MODELS AM-BIO-50,AM-BIO-65, AM-BIO-75, AND AM-BIO-100, AM-BIO-
| Applicant | Asahi Medical Co., Ltd., Rockville MD, US |
| Decision | Substantially Equivalent, May 17, 1999 |
| Received | Oct 21, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983720
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 14, 2006 | Asahi Medical Co., Ltd Asahi AM-BIO Series Hollow Fiber Dialyzers; a wet model single or multiple use dialyzer consisting of hollow fiber membranes of alkyl ether polymer grafted cellulose housed within a plastic casing of Terminated |
MSE | None listed |
| Nov 14, 2006 | Asahi Medical Co., Ltd Asahi AM-BIO D Series Hollow Fiber Dialyzers; a dry model single or multiple use dialyzer consisting of hollow fiber membranes of alkyl ether polymer grafted cellulose housed within a plastic casing o Terminated |
MSE | None listed |
| May 3, 2005 | Asahi Medical Co Ltd Asahi AM-BIO Series Hollow Fiber Dialyzers; a wet model multiple use dialyzer consisting of hollow fiber membranes of alkyl ether polymer grafted cellulose housed within a plastic casing of styrene bu Terminated |
KDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.