Althin Medical AB an Affiliate of Baxter Intl - FDA 510(k) Cleared De...
Recent clearances: PS 15 POLYSULFONE HOLLOW FIBER MEMBRANE HEMODIALYZER, MODEL 239-015, ALTRA FLUX 200 HEMODIALYZER, ALTRA NOVA 200 HEMODIALYZER
27
Total
27
Cleared
0
Denied
FDA 510(k) Regulatory Record - Althin Medical AB an Affiliate of Baxter Intl Gastroenterology & Urology ✕
27 devices
Cleared
Dec 07, 1999
PS 15 POLYSULFONE HOLLOW FIBER MEMBRANE HEMODIALYZER, MODEL 239-015
Gastroenterology & Urology
284d
Cleared
Jul 23, 1998
ALTRA FLUX 200 HEMODIALYZER
Gastroenterology & Urology
514d
Cleared
Jul 23, 1998
ALTRA NOVA 200 HEMODIALYZER
Gastroenterology & Urology
514d
Cleared
Jun 02, 1997
DRAKE WILLOCK SYSTEM & ALTRA TOUCH 1000 DIALYSIS DELIVERY SYSTEM
Gastroenterology & Urology
117d
Cleared
May 21, 1997
DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM ALTRATOUCH 1000 DIALYSATE...
Gastroenterology & Urology
163d
Cleared
Jan 10, 1997
DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM W/SINGLE NEEDLE SINGLE...
Gastroenterology & Urology
415d
Cleared
Dec 27, 1996
ALTERNATE ENCAPSULATING RESIN SYSTEM FOR MCA HEMODIALYZERS
Gastroenterology & Urology
193d
Cleared
Aug 08, 1996
ALTRATOUCH 1000 HEMODIALYSIS DELIVERY SYSTEM
Gastroenterology & Urology
282d
Cleared
Oct 05, 1995
ALTRA FLUX 110 HEMODIALYZER
Gastroenterology & Urology
100d
Cleared
Oct 05, 1995
ALTREX 110 HEMODIALYZER
Gastroenterology & Urology
100d
Cleared
Oct 05, 1995
ALTR NOVA 110 HEMODIALYZER
Gastroenterology & Urology
99d
Cleared
May 30, 1995
ALTRA NOVA(TM) 170 HEMODIALYZER
Gastroenterology & Urology
196d