MSE · Class II · 21 CFR 876.5820

FDA Product Code MSE: Hemodialyzer, Re-use, Low Flux

Leading manufacturers include Baxter Healthcare Corp, Asahi Medical Co., Ltd. and Fresenius USA, Inc..

7
Total
7
Cleared
285d
Avg days
1997
Since

FDA 510(k) Cleared Hemodialyzer, Re-use, Low Flux Devices (Product Code MSE)

7 devices
1–7 of 7
Cleared Nov 15, 2000
PSN HEMODIALYZER, MODEL PSN 130, 150, 170, 210
K001685
Baxter Healthcare Corp
Gastroenterology & Urology · 167d
Cleared May 17, 1999
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-
K983720
Asahi Medical Co., Ltd.
Gastroenterology & Urology · 208d
Cleared Sep 15, 1998
FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX
K970700
Fresenius USA, Inc.
Gastroenterology & Urology · 567d
Cleared Aug 27, 1998
95 C/1.5 CITRIC ACID HEAT PROCESSING OF POLYSULFONE DIALYZERS
K974090
Fresenius Medical Care North America
Gastroenterology & Urology · 302d
Cleared Nov 12, 1997
CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER)
K970654
Baxter Healthcare Corp
Gastroenterology & Urology · 264d
Cleared Nov 12, 1997
CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-90)
K970661
Baxter Healthcare Corp
Gastroenterology & Urology · 264d
Cleared Sep 30, 1997
ASAHI AM-R SERIES DIALYZERS
K970650
Asahi Medical Co., Ltd.
Gastroenterology & Urology · 222d

About Product Code MSE - Regulatory Context