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510(k) K935471

FILTRYZER(TM) by Toray Industries (America), Inc. — Product Code FJI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 1995
Date Received
November 15, 1993
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 Toray Industries (America), Inc.

  • K042370 — TORAYGUIDE GUIDEWIRE (December 17, 2004)
  • K030050 — TORAYSULFONE DIALYZER, BS-L SERIES (September 29, 2003)
  • K002512 — TORAYSULFONE DIALYZER (October 15, 2001)
  • K994198 — HEMOFEEL-CH, MODELS CH-0.35L, CH-0.6L, CH-1.0L (August 25, 2000)
  • K942681 — FILTRYZER (June 22, 1995)
  • K940910 — FILTRYZER (May 4, 1995)
  • K884339 — TORAY FILTRYZER DIALYZERS (March 17, 1989)
  • K883407 — TORAY FILTRYZER BK SERIES (February 27, 1989)
  • K884083 — TORAY VASCULAR PROSTHESIS (January 12, 1989)
  • K882158 — MODIFIED TORAY FILTRYZER DIALYZERS (August 12, 1988)

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  • 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)