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510(k) Data Aggregation

    K Number
    K973584
    Device Name
    MEDTRONIC INSTENT ESOPHACOIL ESOPHAGEAL STENT SYSTEM AND ESOPHACOIL EXTENSION SYSTEM
    Date Cleared
    1998-01-09

    (109 days)

    Product Code
    Regulation Number
    878.3610
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    Applicant Name (Manufacturer) :

    MEDTECH INSTRUMENTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Medtronic InStent EsophaCoil Esophageal Stent System is intended for use in the treatment of esophageal obstructions produced by malignant neoplasms. The Medtronic InStent EsophaCoil Proximal and Distal Extensions are intended for extending previously placed esophageal stents exhibiting tumor overgrowth or tumor ingrowth on the upper or lower portion of the existing stent respectively. The Medtronic InStent EsophaCoil Distal Extension System is intended for use in extending previously implanted esophageal stents exhibiting tumor overgrowth on the distal side of the stent. The Medtronic InStent EsophaCoil Proximal Extension System is intended for use in extending previously implanted esophageal stents exhibiting turnor overgrowth on the proximal side of the stent.
    Device Description
    The Medtronic InStent EsophaCoil Esophageal Stent is a self-expanding, tightly wound spiral Nitinol wire coil which is flared at both ends to enhance fixation. The EsophaCoil Extension is identical to the EsophaCoil Esophageal Stent except that only one end is flared. The non-flared end of the EsophaCoil Extension is inserted into an implanted esophageal stent to extend the length of the stent. The delivery catheter is identical to the currently marketed device. The variable release handle utilizes three independently sliding levers located on the catheter 's proximal end that can release the stent in any sequence order; distal release, center release, or proximal release depending upon which of the sliding levers is pulled first, second, or third.
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