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

    DISPOSABLE 330PSI EXTENSION LINES

    K Number: K120892 · Decision Jun 10, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    124
    Registration Numbers
    124
    Same Product Code
    209
    Applicant Total
    14
    Review Days
    444

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    Basic Information

    Device Name
    DISPOSABLE 330PSI EXTENSION LINES
    K Number
    K120892
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1650
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Coeur, Inc.
    Date Received
    March 23, 2012
    Decision Date
    June 10, 2013
    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 Coeur, Inc.

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