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510(k) K991908

IDEMSA HEMOPHAN HOLLOW FIBER DIALYZERS by Idemsa — Product Code FJI

K991908 is an FDA 510(k) premarket notification submitted by Idemsa for the device "IDEMSA HEMOPHAN HOLLOW FIBER DIALYZERS". The FDA issued a decision of Substantially Equivalent on April 17, 2000. The device falls under product code FJI (Dialyzer, Capillary, Hollow Fiber), a Class II device regulated under 21 CFR 876.5820.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 2000
Date Received
June 7, 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 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)
  • 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)
  • K990159 — DYNAMIC HOLLOW FIBER DIALYZER DH-SERIES, MODEL AH 90111 (April 19, 1999)

FDA data resources