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510(k) K970681

ALTRA NOVA 200 HEMODIALYZER by Althin Medical AB an Affiliate of Baxter Intl — Product Code MSF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 1998
Date Received
February 24, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hemodialyzer, Re-Use, High Flux
Device Class
Class II
Regulation Number
876.5860
Review Panel
GU
Submission Type

Other clearances by Althin Medical AB an Affiliate of Baxter Intl

  • K990643 — PS 15 POLYSULFONE HOLLOW FIBER MEMBRANE HEMODIALYZER, MODEL 239-015 (December 7, 1999)
  • K970679 — ALTRA FLUX 200 HEMODIALYZER (July 23, 1998)
  • K970446 — DRAKE WILLOCK SYSTEM & ALTRA TOUCH 1000 DIALYSIS DELIVERY SYSTEM (June 2, 1997)
  • K964922 — DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM ALTRATOUCH 1000 DIALYSATE DE (May 21, 1997)
  • K955384 — DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM W/SINGLE NEEDLE SINGLE LUMEN (January 10, 1997)
  • K962309 — ALTERNATE ENCAPSULATING RESIN SYSTEM FOR MCA HEMODIALYZERS (December 27, 1996)
  • K954987 — ALTRATOUCH 1000 HEMODIALYSIS DELIVERY SYSTEM (August 8, 1996)
  • K952982 — ALTREX 110 HEMODIALYZER (October 5, 1995)
  • K952983 — ALTR NOVA 110 HEMODIALYZER (October 5, 1995)
  • K952978 — ALTRA FLUX 110 HEMODIALYZER (October 5, 1995)

Other clearances for product code MSF

  • K023615 — GAMBRO POLYFLUX 6 LR, 8 LR AND 10 LR (May 6, 2003)
  • K994390 — GAMBRO POLYFLUX 17R, CAPILLARY DIALYZER/ FILTER (October 26, 2000)
  • K970679 — ALTRA FLUX 200 HEMODIALYZER (July 23, 1998)
  • K970653 — CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER) (March 11, 1998)
  • K970662 — CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-170/CA-210) (March 11, 1998)
  • K970663 — CT CELLULOSER TRIACETATE HOLLOW FIBER DIALYZER (CT-110G/CT-190G) (January 11, 1998)
  • K970648 — PRIMUS HOLLOW FIBER DIALYZER (MODELS 1000,1000S,1350,1350S,2000,2000S) (January 5, 1998)