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

    MEDLINE ANGIOGRAPHIC CONTROL SYRINGE

    K Number: K093830 · Decision Mar 3, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    124
    Registration Numbers
    124
    Same Product Code
    209
    Applicant Total
    238
    Review Days
    444

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    Basic Information

    Device Name
    MEDLINE ANGIOGRAPHIC CONTROL SYRINGE
    K Number
    K093830
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1650
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medline Industries, Inc.
    Date Received
    December 14, 2009
    Decision Date
    March 3, 2011
    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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