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510(k) K991512

ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X by Asahi Medical Co., Ltd. — Product Code FJI

K991512 is an FDA 510(k) premarket notification submitted by Asahi Medical Co., Ltd. for the device "ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X". The FDA issued a decision of Substantially Equivalent on July 29, 1999. The device falls under product code FJI (Dialyzer, Capillary, Hollow Fiber), a Class II device regulated under 21 CFR 876.5820. Asahi Medical Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 1999
Date Received
April 30, 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 Asahi Medical Co., Ltd.

  • K041726 — HIGH FLUX HEMODIALYSIS MEMBRANE DIALYZER OR HIGH FLUX HOLLOW FIBER DIALYZER, MOD (July 23, 2004)
  • K013418 — AM-BIO EXTENDED RANGE SERIES DIALYZER, MODELS WET AND DRY (July 9, 2002)
  • K001250 — APS SERIES DIALYZERS (WET MODELS), APS SERIES DIALYSIS (DRY MODELS) (August 16, 2000)
  • K983720 — ASAHI AM-BIO SERIES DIALYZERS (WET MODELS)& (DRY MODELS), MODELS AM-BIO-50,AM-BI (May 17, 1999)
  • K970650 — ASAHI AM-R SERIES DIALYZERS (September 30, 1997)
  • K914020 — MODIFIED ASAHI PAN-SERIES HEMOFILTERS (March 20, 1992)
  • K901887 — MODIFIED SEPACELL R-SERIES BLOOD FILTERS (August 8, 1990)
  • K896664 — MODIFIED SEPACELL PL-SERIES LEUKOCYTE REMOVAL FILT (January 24, 1990)
  • K896976 — MODIFIED SEPACELL R-500 AND R-500A BLOOD FILTERS (January 24, 1990)
  • K892374 — NEW AM-SERIES DIALYZERS (May 18, 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)
  • K990159 — DYNAMIC HOLLOW FIBER DIALYZER DH-SERIES, MODEL AH 90111 (April 19, 1999)

FDA data resources