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510(k) K992565

A-18 HEMODIALYZER by Althin Medical AB — Product Code FJI

K992565 is an FDA 510(k) premarket notification submitted by Althin Medical AB for the device "A-18 HEMODIALYZER". The FDA issued a decision of Substantially Equivalent on September 23, 1999. The device falls under product code FJI (Dialyzer, Capillary, Hollow Fiber), a Class II device regulated under 21 CFR 876.5820. Althin Medical AB has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 1999
Date Received
August 2, 1999
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

  • K992573 — AF-220 HEMODIALYZER (January 18, 2000)
  • K992563 — A-22 HEMODIALYZER (January 18, 2000)
  • K992564 — AF-180 HEMODIALYZER (January 18, 2000)
  • K992566 — AF-150 HEMODIALYZER (January 18, 2000)
  • K992594 — A-15 HEMODIALYZER (September 24, 1999)
  • K990010 — ALTHIN MEDICAL AB ALTRACART II (April 15, 1999)

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)
  • K991512 — ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X (July 29, 1999)
  • K990159 — DYNAMIC HOLLOW FIBER DIALYZER DH-SERIES, MODEL AH 90111 (April 19, 1999)

FDA data resources