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510(k) K945624

MCA(TM) 160 HEMODIALYZER by Althin Medical AB an Affiliate of Baxter Intl — Product Code FJI

K945624 is an FDA 510(k) premarket notification submitted by Althin Medical AB an Affiliate of Baxter Intl for the device "MCA(TM) 160 HEMODIALYZER". The FDA issued a decision of Substantially Equivalent on May 18, 1995. The device falls under product code FJI (Dialyzer, Capillary, Hollow Fiber), a Class II device regulated under 21 CFR 876.5820. Althin Medical AB an Affiliate of Baxter Intl has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 1995
Date Received
November 15, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dialyzer, Capillary, Hollow Fiber
Device Class
Class II
Regulation Number
876.5820
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)
  • K970681 — ALTRA NOVA 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)
  • K952983 — ALTR NOVA 110 HEMODIALYZER (October 5, 1995)
  • K952982 — ALTREX 110 HEMODIALYZER (October 5, 1995)

Other clearances for product code FJI

  • K190459 — Hemoflow F3 and F4 Dialyzers (August 23, 2019)
  • K122952 — NIPRO PUREFLUX-L HEMODIALYZER (December 4, 2013)
  • K043342 — POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS (May 27, 2005)
  • K010366 — DISPOSABLE STORAGE CAP (November 28, 2001)
  • K011148 — ULTRACONCENTRATOR SYSTEM (June 13, 2001)
  • K002761 — FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS (December 4, 2000)
  • K991908 — IDEMSA HEMOPHAN HOLLOW FIBER DIALYZERS (April 17, 2000)
  • K992594 — A-15 HEMODIALYZER (September 24, 1999)
  • K992565 — A-18 HEMODIALYZER (September 23, 1999)
  • K991512 — ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X (July 29, 1999)

FDA data resources