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510(k) K970650

ASAHI AM-R SERIES DIALYZERS by Asahi Medical Co., Ltd. — Product Code MSE

K970650 is an FDA 510(k) premarket notification submitted by Asahi Medical Co., Ltd. for the device "ASAHI AM-R SERIES DIALYZERS". The FDA issued a decision of Substantially Equivalent on September 30, 1997. The device falls under product code MSE (Hemodialyzer, Re-Use, Low Flux), 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
September 30, 1997
Date Received
February 20, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hemodialyzer, Re-Use, Low Flux
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)
  • K991512 — ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X (July 29, 1999)
  • K983720 — ASAHI AM-BIO SERIES DIALYZERS (WET MODELS)& (DRY MODELS), MODELS AM-BIO-50,AM-BI (May 17, 1999)
  • 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 MSE

  • K001685 — PSN HEMODIALYZER, MODEL PSN 130, 150, 170, 210 (November 15, 2000)
  • K983720 — ASAHI AM-BIO SERIES DIALYZERS (WET MODELS)& (DRY MODELS), MODELS AM-BIO-50,AM-BI (May 17, 1999)
  • K970700 — FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX (September 15, 1998)
  • K974090 — 95 C/1.5 CITRIC ACID HEAT PROCESSING OF POLYSULFONE DIALYZERS (August 27, 1998)
  • K970654 — CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER) (November 12, 1997)
  • K970661 — CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-90) (November 12, 1997)

FDA data resources