BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MODIFIED SEPACELL R-SERIES BLOOD FILTERS

    K Number: K901887 · Decision Aug 8, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    35
    Applicant Total
    16
    Review Days
    104

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    Basic Information

    Device Name
    MODIFIED SEPACELL R-SERIES BLOOD FILTERS
    K Number
    K901887
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Asahi Medical Co., Ltd.
    Date Received
    April 26, 1990
    Decision Date
    August 8, 1990
    Product Code
    CAK
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    CAK Microfilter, Blood Transfusion

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    Other Clearances by Asahi Medical Co., Ltd.

    K Number Device Name
    K041726 HIGH FLUX HEMODIALYSIS MEMBRANE DIALYZER OR HIGH FLUX HOLLOW FIBER DIALYZER, MODELS APS-R, -M, -S, -E, AND -EX
    K013418 AM-BIO EXTENDED RANGE SERIES DIALYZER, MODELS WET AND DRY
    K001250 APS SERIES DIALYZERS (WET MODELS), APS SERIES DIALYSIS (DRY MODELS)
    K991512 ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X
    K983720 ASAHI AM-BIO SERIES DIALYZERS (WET MODELS)& (DRY MODELS), MODELS AM-BIO-50,AM-BIO-65, AM-BIO-75, AND AM-BIO-100, AM-BIO-
    K970650 ASAHI AM-R SERIES DIALYZERS
    K914020 MODIFIED ASAHI PAN-SERIES HEMOFILTERS
    K896976 MODIFIED SEPACELL R-500 AND R-500A BLOOD FILTERS
    K896664 MODIFIED SEPACELL PL-SERIES LEUKOCYTE REMOVAL FILT
    K892375 MODIFIED AM-SERIES DIALYZERS
    Search all 16 clearances from Asahi Medical Co., Ltd. →