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

    018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter

    K Number: K242419 · Decision Nov 15, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    92
    Same Product Code
    402
    Applicant Total
    1
    Review Days
    92

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    Basic Information

    Device Name
    018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter
    K Number
    K242419
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Creagh Medical Ltd. Dba Surmodics, Inc.
    Date Received
    August 15, 2024
    Decision Date
    November 15, 2024
    Product Code
    LIT
    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
    LIT Catheter, Angioplasty, Peripheral, Transluminal

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