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

    NIKKISO ND-14 PARALLEL FLOW DIALYZER

    K Number: K803068 · Decision Mar 4, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    35
    Applicant Total
    11
    Review Days
    90

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    Basic Information

    Device Name
    NIKKISO ND-14 PARALLEL FLOW DIALYZER
    K Number
    K803068
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    NIKKISO CO., LTD.
    Date Received
    December 4, 1980
    Decision Date
    March 4, 1981
    Product Code
    FJG
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FJG Dialyzer, Parallel Flow

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    Other Clearances by NIKKISO CO., LTD.

    K Number Device Name
    K242176 BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series (AL-ADC-E(U), AL-CDC-E(U), C18RDC-E(U), C18BDD-E(U), C18SFD-E(U)
    K242155 DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO)
    K242479 BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series AL-ADC-PU, AL-CDC-PU, C18RDC-PU, C18BDD-PU, C18SFD-PU
    K231589 Blood Tubing Lines for Hemodialysis AV06C-E
    K230514 Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series
    K152938 DBB-06 Hemodialysis Delivery System
    K091978 DBB-06 HEMODIALYSIS DELIVERY SYSTEM
    K082719 NIKKLINE BLOOD TUBING LINES WITH TRANSDUCER PROTECTORS, MODELS AV06A-P, AVO6B-P, AV06C-P
    K061519 MODIFICATION TO DBB-05 HEMODIALYSIS DELIVERY SYSTEM
    K953996 NIKKISO CO, LTD., FLX10GW, 12GW, 15GW, 18GW & 21GW HEMODIALYZERS
    Search all 11 clearances from NIKKISO CO., LTD. →