Company ยท US
Asahi Medical Co., Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 1983 to 2004. Name variants (Inc, Corp, punctuation) are merged.
16510(k) clearances (0 in 12 months)
11recalls (0 in 12 months)
11recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 23, 2004 | K041726 | HIGH FLUX HEMODIALYSIS MEMBRANE DIALYZER OR HIGH FLUX HOLLOW FIBER DIALYZER, MODELS APS-R, -M, -S, -E, AND -EX Asahi Medical Co., Ltd. | KDI |
| Jul 9, 2002 | K013418 | AM-BIO EXTENDED RANGE SERIES DIALYZER, MODELS WET AND DRY Asahi Medical Co., Ltd. | KDI |
| Aug 16, 2000 | K001250 | APS SERIES DIALYZERS (WET MODELS), APS SERIES DIALYSIS (DRY MODELS) Asahi Medical Co., Ltd. | KDI |
| Jul 29, 1999 | K991512 | ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X Asahi Medical Co., Ltd. | FJI |
| May 17, 1999 | K983720 | 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- Asahi Medical Co., Ltd. | MSE |
| Sep 30, 1997 | K970650 | ASAHI AM-R SERIES DIALYZERS Asahi Medical Co., Ltd. | MSE |
| Mar 20, 1992 | K914020 | MODIFIED ASAHI PAN-SERIES HEMOFILTERS Asahi Medical Co., Ltd. | KDI |
| Aug 8, 1990 | K901887 | MODIFIED SEPACELL R-SERIES BLOOD FILTERS Asahi Medical Co., Ltd. | CAK |
| Jan 24, 1990 | K896976 | MODIFIED SEPACELL R-500 AND R-500A BLOOD FILTERS Asahi Medical Co., Ltd. | CAK |
| Jan 24, 1990 | K896664 | MODIFIED SEPACELL PL-SERIES LEUKOCYTE REMOVAL FILT Asahi Medical Co., Ltd. | CAK |
| May 18, 1989 | K892375 | MODIFIED AM-SERIES DIALYZERS Asahi Medical Co., Ltd. | FJI |
| May 18, 1989 | K892374 | NEW AM-SERIES DIALYZERS Asahi Medical Co., Ltd. | FJI |
| Mar 17, 1989 | K885017 | HEMOSORBA CH-500, CH-350 AND CH-180 Asahi Medical Co., Ltd. | FLD |
| Dec 2, 1985 | K854575 | MODIFIED AM-SERIES DIALYZERS Asahi Medical Co., Ltd. | FJI |
| Jan 18, 1985 | K844663 | ASAHI NEW PAN-SERIES HEMOFILTERS Asahi Medical Co., Ltd. | KDI |
| Nov 15, 1983 | K833150 | ASAHI HOLLOW FIBER KIDNEYS, EXCEL Asahi Medical Co., Ltd. | KOC |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 14, 2006 | Asahi Medical Co., Ltd Asahi AM-R Series Hollow Fiber Dialyzers; a dry model single or multiple use dialyzer consisting of hollow fiber membranes of cuprammonium rayon housed within a plastic casing of styrene butadiene blo Terminated |
FJI | K991512 |
| 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 | K983720 |
| 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 | K983720 |
| 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 | K051187 |
| 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 | K041726 |
| May 3, 2005 | Asahi Medical Co Ltd Terumo Clirans Series EE Excebrane Hollow Fiber Dialyzers; a wet model single use dialyzer consisting of hollow fiber membranes (28 microns thick) of vitamin E coated copolymer cellulose housed within Terminated |
KDI | K003425 |
| May 3, 2005 | Asahi Medical Co Ltd Terumo Clirans Series E Excebrane Hollow Fiber Dialyzers; a wet model single use dialyzer consisting of hollow fiber membranes (23 microns thick) of vitamin E coated copolymer cellulose housed within Terminated |
KDI | K003425 |
| 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 | K001250 |
| 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 | K013418 |
| 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 | K983720 |
| 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 | K001250 |