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510(k) Data Aggregation

    K Number
    K092174
    Device Name
    ENABLER-P CATHETER SYSTEM, MODEL 3000
    Manufacturer
    ENDOCROSS, LTD.
    Date Cleared
    2009-12-30

    (162 days)

    Product Code
    DQY
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    ENDOCROSS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ENABLER-P Catheter System is intended to be used in conjunction with a steerable guidewire to access discrete regions of the peripheral vasculature and for guidewire exchange.
    Device Description
    The ENABLER-P Catheter System is comprised of the ENABLER-P Catheter, the ENABLER Pressure Control Unit (PCU), and accessories including a sterile cover, syringe, manifold and extension tube. The ENABLER-P Catheter is a dual-lumen intravascular catheter intended for percutaneous use. It is designed for use in conjunction with a 0.035" guidewire to gain access to locations within the cardiovascular system that are remote from the site of insertion. Once accessed, guidewires may be exchanged within the catheter. In addition, the ENABLER-P Catheter, using a distal balloon, can provide distal anchoring and support the advancement of the guidewire. The ENABLER Pressure Control Unit (PCU) an optional accessory used to automate the inflation and deflation of the catheter's balloon.
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    K Number
    K083833
    Device Name
    ENABLER-P CATHETER, 1000 PART NUMBER:1160
    Manufacturer
    ENDOCROSS, LTD.
    Date Cleared
    2009-05-22

    (150 days)

    Product Code
    DQY
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    ENDOCROSS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ENABLER-P Catheter is intended to be used in conjunction with a steerable guidewire to access discrete regions of the peripheral vasculature and for guidewire exchange.
    Device Description
    The ENABLER-P Catheter is a dual-lumen intravascular catheter intended for percutaneous use. It is designed for use in conjunction with a 0.035" guidewire to gain access to locations within the cardiovascular system that are remote from the site of insertion. Once accessed, guidewires may be exchanged within the catheter. In addition, the ENABLER-P Catheter can provide distal anchoring and support the advancement of the guidewire. The ENABLER-P Catheter is packaged in a Tyvek/Poly pouch to form a sterile barrier. The packaged catheter is sterilized by ethylene oxide gas. The ENABLER-P Catheter is provided "STERILE" and "Non-pyrogenic", and is intended for single use only.
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    K Number
    K082339
    Device Name
    ENABLER-P SUPPORT CATHETER
    Manufacturer
    ENDOCROSS, LTD.
    Date Cleared
    2008-11-20

    (98 days)

    Product Code
    DQY
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    ENDOCROSS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ENABLER-P Support Catheter is intended to be used in conjunction with a steerable guidewire to access discrete regions of the peripheral vasculature and for guidewire exchange.
    Device Description
    The ENABLER-P Support Catheter is a dual-lumen intravascular catheter intended for percutaneous use. It is designed for use in conjunction with a 0.035" guidewire to gain access to locations within the cardiovascular system that are remote from the site of insertion. Once accessed, guidewires may be exchanged within the catheter. In addition, the ENABLER-P Support Catheter can provide distal anchoring and support the advancement of the guidewire. The ENABLER-P Support Catheter is packaged in a Tyvek/Poly pouch to form a sterile barrier. The packaged catheter is sterilized by ethylene oxide gas. The ENABLER-P Support Catheter is provided "STERILE" and "Non-pyrogenic", and is intended for single use only. The ENABLER-P Support Catheter is similar in basic materials, design, construction and mechanical performance to a combination of the predicate devices.
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