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

    PENTATRASFU BLOOD TRANSFUSION SETS

    K Number: K041496 · Decision Jun 30, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    29
    Applicant Total
    2
    Review Days
    391

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    Basic Information

    Device Name
    PENTATRASFU BLOOD TRANSFUSION SETS
    K Number
    K041496
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pentaferte S.P.A
    Date Received
    June 4, 2004
    Decision Date
    June 30, 2005
    Product Code
    BRZ
    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
    BRZ Set, Blood Transfusion

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    Other Clearances by Pentaferte S.P.A

    K Number Device Name
    K041495 PENTADEFLUE IV SOLUTION ADMINISTRATION SETS