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510(k) Data Aggregation

    K Number
    K110241
    Device Name
    ENDOLOGIX GUIDEWIRE
    Manufacturer
    TECHDEVICE CORPORATION
    Date Cleared
    2011-02-25

    (29 days)

    Product Code
    DQX, DOX
    Regulation Number
    870.1330
    Why did this record match?
    Applicant Name (Manufacturer) :

    TECHDEVICE CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Guidewire facilitates placement and exchange of catheters and other instruments in the peripheral vasculature. This guidewire is not intended for use in the coronary arteries or neurovasculature.
    Device Description
    The Guidewire is constructed of a stainless steel core wire and a platinum coil welded/brazed in place over the core wire. The coil may cover the entire core wire or just the floppy distal portion. The exposed core wire and or the coil may be uncoated stainless steel or coated with a PTFE spray or a PTFE jacket. Platinum Tungsten marker bands may be placed under the coil to aid in visualization.
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    K Number
    K053251
    Device Name
    TECHDEVICE GUIDEWIRE
    Manufacturer
    TECHDEVICE CORPORATION
    Date Cleared
    2006-03-08

    (107 days)

    Product Code
    DQX
    Regulation Number
    870.1330
    Why did this record match?
    Applicant Name (Manufacturer) :

    TECHDEVICE CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TechDevice Guidewire facilitates placement and exchange of catheters and other instruments in the peripheral vasculature. This device is not indicated for neuro, or cardiac use.
    Device Description
    The Guidewire is constructed of a stainless steel core wire and a stainless steel or platinum coil welded/brazed in place over the core wire. The coil may cover the entire or just the floppy distal portion. The exposed core wire and or the coil may be uncoated stainless steel or coated with a PTFE spray or a PTFE jacket. Platinum marker bands may be placed under the coil to aid in visualization. Exit markers may be printed on the proximal section of the guidewire to aid the physician in determining the depth of insertion.
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    K Number
    K051137
    Device Name
    TECHDEVICE OCCLUSION BALLOON CATHETER
    Manufacturer
    TECHDEVICE CORPORATION
    Date Cleared
    2006-02-24

    (296 days)

    Product Code
    MJN
    Regulation Number
    870.4450
    Why did this record match?
    Applicant Name (Manufacturer) :

    TECHDEVICE CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TechDevice Percutaneous Occlusion Balloon Catheter is for temporary vessel occlusion, where the stoppage of blood flow is desirable. This device is not indicated for neuro, or cardiac use.
    Device Description
    The occlusion balloon catheter consists of a latex balloon (outside diameter 11mm, 15mm, 18mm or 27mm) mounted on the distal end of a 5 French catheter shaft ( 45cm -- 100cm in length). The dual-lumen catheter shaft terminates in a proximal molded bifurcation attached to luer connectors. The hub labeled "Distal" connects to the distal lumen which passes completely through the catheter and can be used for catheter placement over a guidewire, or fluid infusion into the vessel. The second hub, labeled "Balloon", terminates under the balloon via an opening skived into the extrusion. This is used for balloon inflation.
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    K Number
    K053028
    Device Name
    TECHDEVICE GUIDEWIRE
    Manufacturer
    TECHDEVICE CORPORATION
    Date Cleared
    2006-01-31

    (96 days)

    Product Code
    OCY, KOG
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    TECHDEVICE CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TechDevice Guidewire facilitates placement and exchange of catheters and other instruments in the alimentary tract. This device is not indicated for neuro or cardiac use.
    Device Description
    The Guidewire is constructed of a stainless steel core wire and a stainless steel or platinum coil welded/brazed in place over the core wire. The coll may cover the entire core wire or just the floppy distal portion. The exposed core wire and or the coil may be uncoated stainless steel or coated with a PTFE spray or a PTFE jacket. Platinum iridium marker bands may be placed under the coil to aid in visualization. Exit markers may be printed on the proximal section of the guidewire to aid the physician in determining the depth of insertion.
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