BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇪 Ireland

    Emerge Monorail PTCA Dilatation Catheter

    K Number: K220629 · Decision Mar 24, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    70
    Same Product Code
    81
    Applicant Total
    23
    Review Days
    20

    Basic Information

    Device Name
    Emerge Monorail PTCA Dilatation Catheter
    K Number
    K220629
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.5100
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Boston Scientific
    Date Received
    March 4, 2022
    Decision Date
    March 24, 2022
    Product Code
    LOX
    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
    LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous

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