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510(k) Data Aggregation

    K Number
    K983297
    Device Name
    MEDTRONIC INSTENT ESOPHACOIL ESOPHAGEAL STENT SYSTEM WITH SLOW RELEASE
    Date Cleared
    1998-12-18

    (88 days)

    Product Code
    Regulation Number
    878.3610
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDTRONIC INSTENT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Medtronic InStent EsophaCoil Esophageal Stent System with Slow Release in indicated for use in the treatment of esophageal obstructions produced by malignant neoplasms.
    Device Description
    The Medtronic InStent EsophaCoil Esophageal Stent System with Slow Release is self-expandable metal stent which is mounted on a delivery catheter. The stent is manufactured from a nickel titanium (Nitinol) material and is comprised of a center stenting section of adjacent coils and two flared ends which enhance fixation. The delivery catheter is manufactured from a thermoplastic material with a tapered end and flexible tip. The stent is wound in a reduced diameter configuration and held in place by a restraining means. The restraining means in connected to the "slow release" handle on the proximal end of the catheter. The slow release allows the stent to be released from the catheter in a fixed and controlled speed manner.
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