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510(k) K896976

MODIFIED SEPACELL R-500 AND R-500A BLOOD FILTERS by Asahi Medical Co., Ltd. — Product Code CAK

K896976 is an FDA 510(k) premarket notification submitted by Asahi Medical Co., Ltd. for the device "MODIFIED SEPACELL R-500 AND R-500A BLOOD FILTERS". The FDA issued a decision of Substantially Equivalent on January 24, 1990. The device falls under product code CAK (Microfilter, Blood Transfusion), a Class II device regulated under 21 CFR 880.5440. Asahi Medical Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 1990
Date Received
December 13, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Microfilter, Blood Transfusion
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
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)
  • K892374 — NEW AM-SERIES DIALYZERS (May 18, 1989)

Other clearances for product code CAK

  • K061103 — HAEMONETICS 40U RBC FILTER BAG (May 17, 2006)
  • K022477 — SUMMIT MEDICAL LTD TRANSFUSION FILTER, MODEL LF400 & SUMMIT MEDICAL LTD TRANSFUS (October 25, 2002)
  • K000719 — NEOCARE 20 MICRON BLOOD FILTER (May 30, 2000)
  • K990310 — CHARTER MEDICAL, LTD MP 450 (40 MICRON FILTER) (August 30, 1999)
  • K982822 — FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER MODEL 4C7701, FENWAL 20 MICRON PED (September 30, 1998)
  • K972159 — FENWAL 40 MICRON TRANSFUSION FILTER (July 23, 1997)
  • K970225 — ALPHA MICRON 20/40 MICROAGGREGATE FILTER (February 14, 1997)
  • K960993 — PALL SQ40S BLOOD FILTER (SQ40S/SQ40ST) (April 22, 1996)
  • K955515 — ALPHA MICRON 20 MICROAGGREGATE FILTER (February 12, 1996)
  • K904221 — SEPACELL(R) PL-5A/10A LEUKOCYTE REMOVAL FILTERS (October 26, 1990)

FDA data resources