Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Althin Medical AB an Affiliate of Baxter Intl

FDA 510(k) & PMA Approved Devices — 27 products

Total Devices27
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K990643 PS 15 POLYSULFONE HOLLOW FIBER MEMBRANE HEMODIALYZER, MODEL 239-015KDI1999-12-07 View
510(k) K970681 ALTRA NOVA 200 HEMODIALYZERMSF1998-07-23 View
510(k) K970679 ALTRA FLUX 200 HEMODIALYZERMSF1998-07-23 View
510(k) K970446 DRAKE WILLOCK SYSTEM & ALTRA TOUCH 1000 DIALYSIS DELIVERY SYSTEMKDI1997-06-02 View
510(k) K964922 DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM ALTRATOUCH 1000 DIALYSATE DELIVERY SYSTEMKDI1997-05-21 View
510(k) K955384 DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM W/SINGLE NEEDLE SINGLE LUMEN OPTIONKDI1997-01-10 View
510(k) K962309 ALTERNATE ENCAPSULATING RESIN SYSTEM FOR MCA HEMODIALYZERSFJI1996-12-27 View
510(k) K954987 ALTRATOUCH 1000 HEMODIALYSIS DELIVERY SYSTEMKDI1996-08-08 View
510(k) K952983 ALTR NOVA 110 HEMODIALYZERKDI1995-10-05 View
510(k) K952978 ALTRA FLUX 110 HEMODIALYZERKDI1995-10-05 View
510(k) K952982 ALTREX 110 HEMODIALYZERKDI1995-10-05 View
510(k) K945625 ALTRA NOVA(TM) 140 HEMODIALYZERKDI1995-05-30 View
510(k) K945621 ALTRA NOVA(TM) 170 HEMODIALYZERKDI1995-05-30 View
510(k) K945622 MCA(TM) 180 HEMODIALYZERFJI1995-05-25 View
510(k) K945542 ALTRA FLUX(TM) 170 HEMODIALYZERKDI1995-05-23 View
510(k) K945620 ALTRA FLUX(TM) 140 HEMODIALYZERKDI1995-05-18 View
510(k) K945623 MCA(TM) 130 HEMODIALYZERFJI1995-05-18 View
510(k) K945624 MCA(TM) 160 HEMODIALYZERFJI1995-05-18 View
510(k) K945631 155 SCE(TM) HEMODIALYZERFJI1995-05-18 View
510(k) K945595 ALTREX(R) 200 HEMODIALYZERKDI1995-03-08 View
↑