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510(k) K882158

MODIFIED TORAY FILTRYZER DIALYZERS by Toray Industries (America), Inc. — Product Code FJI

K882158 is an FDA 510(k) premarket notification submitted by Toray Industries (America), Inc. for the device "MODIFIED TORAY FILTRYZER DIALYZERS". The FDA issued a decision of Substantially Equivalent on August 12, 1988. The device falls under product code FJI (Dialyzer, Capillary, Hollow Fiber), a Class II device regulated under 21 CFR 876.5820. Toray Industries (America), Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 1988
Date Received
May 23, 1988
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)
  • K935471 — FILTRYZER(TM) (May 19, 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)

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