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510(k) K833150

ASAHI HOLLOW FIBER KIDNEYS, EXCEL by Asahi Medical Co., Ltd. — Product Code KOC

K833150 is an FDA 510(k) premarket notification submitted by Asahi Medical Co., Ltd. for the device "ASAHI HOLLOW FIBER KIDNEYS, EXCEL". The FDA issued a decision of Substantially Equivalent on November 15, 1983. The device falls under product code KOC (Accessories, Blood Circuit, Hemodialysis), 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
November 15, 1983
Date Received
September 15, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Blood Circuit, Hemodialysis
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)
  • 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)

Other clearances for product code KOC

  • K242479 — BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR (May 15, 2025)
  • K242176 — BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR (May 15, 2025)
  • K231589 — Blood Tubing Lines for Hemodialysis AV06C-E (July 28, 2023)
  • K230514 — Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for (June 16, 2023)
  • K201207 — CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and In (September 18, 2020)
  • K172238 — CAREline Airless Hemodialysis Blood Tubing Sets (December 14, 2017)
  • K160749 — CRIT-LINE III Blood Chamber II (April 15, 2016)
  • K152953 — CRIT-LINE CLIP (CLIC) BLOOD CHAMBER (November 5, 2015)
  • K141997 — CRIT-LINE IV SYSTEM (April 1, 2015)
  • K141281 — CRIT-LINE CLIP (CLIC) BLOOD CHAMBER (August 14, 2014)

FDA data resources