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

    EQUASHIELD CLOSED SYSTEM DRUG TRANSFER DEVICE (CSTD)

    K Number: K132899 · Decision May 13, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    40
    Applicant Total
    5
    Review Days
    239

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    Basic Information

    Device Name
    EQUASHIELD CLOSED SYSTEM DRUG TRANSFER DEVICE (CSTD)
    K Number
    K132899
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Equashield Medical , Ltd.
    Date Received
    September 16, 2013
    Decision Date
    May 13, 2014
    Product Code
    ONB
    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
    ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System

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    Other Clearances by Equashield Medical , Ltd.

    K Number Device Name
    K221513 Equashield Closed System Transfer Device
    K170706 Equashield Closed System drug Transfer Device (CSTD)
    K150219 Equashield Closed System drug Transfer Device (CSTD)
    K101940 EQUASHIELD SYSTEM PROTECTIVE PLUS