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Althin Medical AB an Affiliate of Baxter Intl

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
27
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K990643PS 15 POLYSULFONE HOLLOW FIBER MEMBRANE HEMODIALYZER, MODEL 239-015December 7, 1999
K970679ALTRA FLUX 200 HEMODIALYZERJuly 23, 1998
K970681ALTRA NOVA 200 HEMODIALYZERJuly 23, 1998
K970446DRAKE WILLOCK SYSTEM & ALTRA TOUCH 1000 DIALYSIS DELIVERY SYSTEMJune 2, 1997
K964922DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM ALTRATOUCH 1000 DIALYSATE DELIVERY SYSTEMMay 21, 1997
K955384DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM W/SINGLE NEEDLE SINGLE LUMEN OPTIONJanuary 10, 1997
K962309ALTERNATE ENCAPSULATING RESIN SYSTEM FOR MCA HEMODIALYZERSDecember 27, 1996
K954987ALTRATOUCH 1000 HEMODIALYSIS DELIVERY SYSTEMAugust 8, 1996
K952978ALTRA FLUX 110 HEMODIALYZEROctober 5, 1995
K952983ALTR NOVA 110 HEMODIALYZEROctober 5, 1995
K952982ALTREX 110 HEMODIALYZEROctober 5, 1995
K945621ALTRA NOVA(TM) 170 HEMODIALYZERMay 30, 1995
K945625ALTRA NOVA(TM) 140 HEMODIALYZERMay 30, 1995
K945622MCA(TM) 180 HEMODIALYZERMay 25, 1995
K945542ALTRA FLUX(TM) 170 HEMODIALYZERMay 23, 1995
K945624MCA(TM) 160 HEMODIALYZERMay 18, 1995
K945623MCA(TM) 130 HEMODIALYZERMay 18, 1995
K945631155 SCE(TM) HEMODIALYZERMay 18, 1995
K945620ALTRA FLUX(TM) 140 HEMODIALYZERMay 18, 1995
K945595ALTREX(R) 200 HEMODIALYZERMarch 8, 1995