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510(k) Data Aggregation

    K Number
    K110491
    Device Name
    BACKSTOP CATHETER
    Manufacturer
    PLUROMED, INC.
    Date Cleared
    2011-03-16

    (22 days)

    Product Code
    KOD, INT
    Regulation Number
    876.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    PLUROMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 3F BackStop Catheter is indicated for use by physicians for facilitating access to the urinary tract, either through a retrograde or antegrade route, and may be used in conjunction with a guidewire or for the injection of gels, such as BackStop™, or fluid into the urinary tract.
    Device Description
    The BackStop Catheter is a 100cm, 3 French, single lumen catheter with a radiopaque tip that facilitates access to the urinary tract. The catheter is inserted over a guidewire or through the working channel of a ureteroscope and is advanced through the urinary tract to the desired location. Once in place, fluid may be injected via the catheter. The device is a single lumen catheter with a stainless steel braid and a standard female luer lock hub on the proximal end.
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    K Number
    K103349
    Device Name
    BACKSTOP CATHETER
    Manufacturer
    PLUROMED, INC.
    Date Cleared
    2011-01-07

    (52 days)

    Product Code
    KOD
    Regulation Number
    876.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    PLUROMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 3F BackStop Catheter is indicated for use by physicians for facilitating access to the urinary tract, either through a retrograde or antegrade route, and may be used in conjunction with a guidewire or for the injection of gels, such as BackStop™, or fluid into the urinary tract.
    Device Description
    The Pluromed 3F BackStop™ Catheter is a 100 cm, 3F, single lumen, radiopaque catheter that facilitates access to the urinary tract. The catheter may be inserted over a guidewire or through the working channel of an ureteroscope and is advanced through the urinary tract to the desired location in the ureter. Once in place fluid or gels, such as BackStop™, may be injected via the catheter. The device is a single lumen catheter with a stainless steel braid and a standard female luer lock hub on the proximal end.
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    K Number
    K090430
    Device Name
    BACKSTOP AND BACKSTOP INJECTOR
    Manufacturer
    PLUROMED, INC.
    Date Cleared
    2009-06-02

    (103 days)

    Product Code
    ONJ, PER
    Regulation Number
    876.4680
    Why did this record match?
    Applicant Name (Manufacturer) :

    PLUROMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BackStop is intended for use in the ureter to prevent migration of renal calculi during intracorporeal lithotripsy procedures.
    Device Description
    BackStop™ is a self-forming polymeric plug with reverse thermosensitive properties. At room temperature it is viscous but injectable. When the temperature of the plug increases , its viscosity increases and it forms a plug that is intended for use in the ureter to prevent migration of renal calculi during intracorporeal lithotripsy procedures. The material is water soluble and is removed by irrigating the plug with saline.
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    K Number
    K090270
    Device Name
    BACKSTOP CATHETER, MODEL 60-0000-3100
    Manufacturer
    PLUROMED, INC.
    Date Cleared
    2009-05-15

    (100 days)

    Product Code
    KOD, IND
    Regulation Number
    876.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    PLUROMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BackStop Catheter is indicated for use by physicians for facilitating access to the urinary tract, either through a retrograde or antegrade route, and may be used in conjunction with a guidewire or for the injection of fluid into the urinary tract.
    Device Description
    The BackStop Catheter is a 100cm, 3F single lumen radiopaque catheter to facilitate access to the urinary tract. The catheter is inserted over a guidewire or through the working channel of an ureteroscope and is progressed through the urinary tract to the desired ureter location. Once in place fluid may be injected via the catheter. The device is a single lumen catheter with a stainless steel braid and a standard female luer lock hub on the proximal end.
    Ask a Question

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