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

    ULTRA-ASEPT ANGIOGRAPHIC SYRINGE/SPARE

    K Number: K823256 · Decision Dec 30, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    124
    Registration Numbers
    124
    Same Product Code
    209
    Applicant Total
    21
    Review Days
    59

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    Basic Information

    Device Name
    ULTRA-ASEPT ANGIOGRAPHIC SYRINGE/SPARE
    K Number
    K823256
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1650
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Vertex Medical Corp.
    Date Received
    November 1, 1982
    Decision Date
    December 30, 1982
    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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