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

    ANGIOGRAPHY SYRINGE KITS

    K Number: K933846 · Decision Dec 13, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    124
    Registration Numbers
    124
    Same Product Code
    209
    Applicant Total
    6
    Review Days
    494

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    Basic Information

    Device Name
    ANGIOGRAPHY SYRINGE KITS
    K Number
    K933846
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1650
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Angiodynamics, Div. E-Z-Em, Inc.
    Date Received
    August 6, 1993
    Decision Date
    December 13, 1994
    Product Code
    DXT
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DXT Injector And Syringe, Angiographic

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    Other Clearances by Angiodynamics, Div. E-Z-Em, Inc.

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