Medical Device Manufacturer · US , Miami Lakes , FL

Althin Medical AB an Affiliate of Baxter Intl

27 submissions · 27 cleared · Since 1991
27
Total
27
Cleared
0
Denied

Althin Medical AB an Affiliate of Baxter Intl — FDA 510(k) Submissions

Althin Medical AB an Affiliate of Baxter Intl has submitted 27 FDA 510(k) premarket notifications since 1991, of which 27 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Dialyzer, High Permeability With Or Without Sealed Dialysate System, Dialyzer, Capillary, Hollow Fiber, Hemodialyzer, Re-use, High Flux, Set, Tubing, Blood, With And Without Anti-regurgitation Valve . Use the specialty filter in the sidebar to narrow results.

27 devices
1–25 of 27
PS 15 POLYSULFONE HOLLOW FIBER MEMBRANE HEMODIALYZER, MODEL 239-015
K990643 · KDI Dialyzer, High... · Gastroenterology & Urology
Dec 1999 284d
ALTRA FLUX 200 HEMODIALYZER
K970679 · MSF Hemodialyzer, Re-use,... · Gastroenterology & Urology
Jul 1998 514d
ALTRA NOVA 200 HEMODIALYZER
K970681 · MSF Hemodialyzer, Re-use,... · Gastroenterology & Urology
Jul 1998 514d
DRAKE WILLOCK SYSTEM & ALTRA TOUCH 1000 DIALYSIS DELIVERY SYSTEM
K970446 · KDI Dialyzer, High... · Gastroenterology & Urology
Jun 1997 117d
DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM ALTRATOUCH 1000 DIALYSATE DELIVERY SYSTEM
K964922 · KDI Dialyzer, High... · Gastroenterology & Urology
May 1997 163d
DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM W/SINGLE NEEDLE SINGLE LUMEN OPTION
K955384 · KDI Dialyzer, High... · Gastroenterology & Urology
Jan 1997 415d
ALTERNATE ENCAPSULATING RESIN SYSTEM FOR MCA HEMODIALYZERS
K962309 · FJI Dialyzer, Capillary,... · Gastroenterology & Urology
Dec 1996 193d
ALTRATOUCH 1000 HEMODIALYSIS DELIVERY SYSTEM
K954987 · KDI Dialyzer, High... · Gastroenterology & Urology
Aug 1996 282d
ALTRA FLUX 110 HEMODIALYZER
K952978 · KDI Dialyzer, High... · Gastroenterology & Urology
Oct 1995 100d
ALTREX 110 HEMODIALYZER
K952982 · KDI Dialyzer, High... · Gastroenterology & Urology
Oct 1995 100d
ALTR NOVA 110 HEMODIALYZER
K952983 · KDI Dialyzer, High... · Gastroenterology & Urology
Oct 1995 99d
ALTRA NOVA(TM) 170 HEMODIALYZER
K945621 · KDI Dialyzer, High... · Gastroenterology & Urology
May 1995 196d
ALTRA NOVA(TM) 140 HEMODIALYZER
K945625 · KDI Dialyzer, High... · Gastroenterology & Urology
May 1995 196d
MCA(TM) 180 HEMODIALYZER
K945622 · FJI Dialyzer, Capillary,... · Gastroenterology & Urology
May 1995 191d
ALTRA FLUX(TM) 170 HEMODIALYZER
K945542 · KDI Dialyzer, High... · Gastroenterology & Urology
May 1995 190d
ALTRA FLUX(TM) 140 HEMODIALYZER
K945620 · KDI Dialyzer, High... · Gastroenterology & Urology
May 1995 184d
MCA(TM) 130 HEMODIALYZER
K945623 · FJI Dialyzer, Capillary,... · Gastroenterology & Urology
May 1995 184d
MCA(TM) 160 HEMODIALYZER
K945624 · FJI Dialyzer, Capillary,... · Gastroenterology & Urology
May 1995 184d
155 SCE(TM) HEMODIALYZER
K945631 · FJI Dialyzer, Capillary,... · Gastroenterology & Urology
May 1995 183d
ALTREX(R) 200 HEMODIALYZER
K945595 · KDI Dialyzer, High... · Gastroenterology & Urology
Mar 1995 114d
ALTRES(R) 140 HEMODIALYZER
K945596 · KDI Dialyzer, High... · Gastroenterology & Urology
Mar 1995 114d
ALTRES(R) 170 HEMODIALYZER
K945597 · KDI Dialyzer, High... · Gastroenterology & Urology
Mar 1995 114d
MCA 200 HEMPDIALYZER
K926372 · FJI Dialyzer, Capillary,... · Gastroenterology & Urology
Feb 1995 783d
ALTRA FLUX 200 HEMODIALYZER
K926373 · KDI Dialyzer, High... · Gastroenterology & Urology
Feb 1995 783d
ALTRA NOVA 200 HEMODAILYZER
K926379 · KDI Dialyzer, High... · Gastroenterology & Urology
Feb 1995 783d
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