FDA 510(k) Applications for Medical Device Product Code "MSE"
(Hemodialyzer, Re-Use, Low Flux)
FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K983720 |
ASAHI MEDICAL CO., LTD. |
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- |
05/17/1999 |
K970650 |
ASAHI MEDICAL CO., LTD. |
ASAHI AM-R SERIES DIALYZERS |
09/30/1997 |
K970661 |
BAXTER HEALTHCARE CORP. |
CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-90) |
11/12/1997 |
K970654 |
BAXTER HEALTHCARE CORP. |
CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER) |
11/12/1997 |
K001685 |
BAXTER HEALTHCARE CORP. |
PSN HEMODIALYZER, MODEL PSN 130, 150, 170, 210 |
11/15/2000 |
K974090 |
FRESENIUS MEDICAL CARE NORTH AMERICA |
95 C/1.5 CITRIC ACID HEAT PROCESSING OF POLYSULFONE DIALYZERS |
08/27/1998 |
K970700 |
FRESENIUS USA, INC. |
FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX |
09/15/1998 |
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