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510(k) Data Aggregation

    K Number
    K013266
    Device Name
    RUSCH POLYFLEX STENT KIT
    Manufacturer
    RUSCH INTL.
    Date Cleared
    2001-11-27

    (57 days)

    Product Code
    NYT
    Regulation Number
    878.3720
    Why did this record match?
    Product Code :

    NYT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Airway complications such as anastomosis ans stenosis, Trachea-esophageal fistula, Stenosis of the central ridence obsphagetee trachea and main bronchus), and arrways (Such as trictures due to tumors (Trachea and main bronchus) . Compression or strictures due to tumors (trachea and main bronchus) Stenosis of the central airways (such as trachea and main bronchus) Tracheo Esophageal fistula Airway complications such as-anastomosis and stenosis
    Device Description
    The Rusch Polyflex Stent Kit consists of a medical silicone file Rusch folyrica beene core along with the components Suppored by insert the device into the human body. These required to inocre one he Introducer Sleeve, the Stent Loader, Soft Positioner, and Blue Stopper. This amendment changes the material of the Insertion ffirs amending to adds indicator markings to the stent and provides for a non-sterile version.
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    K Number
    K982614
    Device Name
    RUSCH POLYFLEX STENT KIT
    Manufacturer
    RUSCH INTL.
    Date Cleared
    1998-12-04

    (130 days)

    Product Code
    NYT
    Regulation Number
    878.3720
    Why did this record match?
    Product Code :

    NYT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Airway complications such as anastomosis ans stenosis, Trachea-esophageal fistula, Stenosis of the central airways(such as the trachea and main bronchus), and Compression or strictures due to tumors (Trachea and main bronchus) .
    Device Description
    The Rüsch Polyflex Stent Kit consists of a medical silicone supported by a polyester core along with the components required to insert the device into the human body. These components consist of the Introducer Sleeve, the Stent Loader, Soft Positioner, and Blue Stopper.
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