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Asahi Medical Co., Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
16
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K041726HIGH FLUX HEMODIALYSIS MEMBRANE DIALYZER OR HIGH FLUX HOLLOW FIBER DIALYZER, MODELS APS-R, -M, -S, -July 23, 2004
K013418AM-BIO EXTENDED RANGE SERIES DIALYZER, MODELS WET AND DRYJuly 9, 2002
K001250APS SERIES DIALYZERS (WET MODELS), APS SERIES DIALYSIS (DRY MODELS)August 16, 2000
K991512ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-XJuly 29, 1999
K983720ASAHI AM-BIO SERIES DIALYZERS (WET MODELS)& (DRY MODELS), MODELS AM-BIO-50,AM-BIO-65, AM-BIO-75, ANDMay 17, 1999
K970650ASAHI AM-R SERIES DIALYZERSSeptember 30, 1997
K914020MODIFIED ASAHI PAN-SERIES HEMOFILTERSMarch 20, 1992
K901887MODIFIED SEPACELL R-SERIES BLOOD FILTERSAugust 8, 1990
K896664MODIFIED SEPACELL PL-SERIES LEUKOCYTE REMOVAL FILTJanuary 24, 1990
K896976MODIFIED SEPACELL R-500 AND R-500A BLOOD FILTERSJanuary 24, 1990
K892374NEW AM-SERIES DIALYZERSMay 18, 1989
K892375MODIFIED AM-SERIES DIALYZERSMay 18, 1989
K885017HEMOSORBA CH-500, CH-350 AND CH-180March 17, 1989
K854575MODIFIED AM-SERIES DIALYZERSDecember 2, 1985
K844663ASAHI NEW PAN-SERIES HEMOFILTERSJanuary 18, 1985
K833150ASAHI HOLLOW FIBER KIDNEYS, EXCELNovember 15, 1983