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510(k) Data Aggregation

    K Number
    K971688
    Device Name
    IVT 0.014 PTFE-COATED TRACKWIRE
    Date Cleared
    1997-12-11

    (218 days)

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

    BOSTON SCIENTIFIC /INTERNATIONAL TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The IVT 0.014" PTFE-Coated Trackwire is indicated for use in coronary and peripheral vessels to facilitate the navigation and placement of angioplasty interventional catheters. The 0.014" Trackwire is not indicated for cerebrovascular use.
    Device Description
    The IVT 0.014" PTFE-Coated Trackwires have a nominal diameter of 0.014 inches and nominal lengths from 175 to 300 centimeters. The distal 1-3 centimeters of the Trackwire is shapeable. The distal 2-6 centimeters contains a radiopaque coil. The proximal section of the Trackwire is coated with a fluorinated polymer.
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    K Number
    K963663
    Device Name
    11F GUIDING CATHETER
    Date Cleared
    1997-01-13

    (122 days)

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

    BOSTON SCIENTIFIC /INTERNATIONAL TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The IVT 11F Guiding Catheter is a standard quiding catheter intended for use in the coronary vasculature as a conduit for other medical devices such as diagnostic and therapeutic catheters and quidewires. Thus, the IVT 11F Guiding Catheter acts to facilitate access for these other medical devices. This device is intended for single use only. IVT's 11F Guiding Catheter is indicated for use during interventional diagnostic cardiovascular procedures in hospital settings which are appropriate for these types of procedures.
    Device Description
    The IVT 11F Guiding Catheter is a series of standard cardiovascular guiding catheters with models corresponding to standard catheter curvature types. The IVT 11F Guiding Catheter contains a single lumen which acts as a conduit to provide access for other medical devices to the coronary vasculature. The device's proximal end contains a polycarbonate female luer fitting which can be connected to other equipment used in cardiovascular procedures. The 11F Guiding Catheter device is offered in a catheter working length of 94 cm. The shaft is designed with a braided wire reinforcement and can include side holes to enable vessel perfusion during placement. The 11F Guiding Catheter's distal end is shaped to accommodate various anatomic configurations. The 11F Guiding Catheter curvatures include the FL 3.5, FL 4.0, FL 5.0, FR 3.5, FR 4.0, FR 5.0, Multi-purpose Graft, Modified Amplatz, Left Amplatz, Right Coronary Bypass, and Hockey Stick standard catheter shape types. The distal tip of the device is a "soft" tip design. All IVT 11F Guiding Catheter device packaging configurations are supplied as sterile devices and intended for single use only.
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    K Number
    K954552
    Device Name
    RAILWIRE
    Date Cleared
    1996-04-29

    (210 days)

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

    BOSTON SCIENTIFIC /INTERNATIONAL TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The IVT 0.014" Railwire™ is intended to facilitate the navigation and placement of angioplasty and interventional devices through tortuous peripheral and coronary vessels.
    Device Description
    The IVT 0.014" Railwire™ is constructed from a stainless steel core wire that is distally tapered and fitted with a gold alloy coil. To minimize blood vessel trauma and to facilitate maneuverability, the distal tip is extremely flexible. The core is nominally 0.0136" in diameter. The coil, approximately 1.2 * in length with a nominal diameter of 0.0136", is made from a single continuous radiopaque gold alloy wire that has two different wind spacings. Both the core and coil are single continuous pieces that are secured together at two points. The core is inserted into the coil lumen and attached at the distal end utilizing a plasma arc technology that brazes the end of the gold alloy coil to the cylindrical bulb. This special process results in the formation of a gold alloy sphere. The proximal end of the coil is secured to the stainless steel core using a silver alloy solder. This design provides both unibody integrity and flexibility. The IVT Railwire™ will be manufactured in various lengths ranging from 100 to 300 cms. All Railwire™s will receive a final parylene (polypara-xylyene) coating prior to packaging and sterilization. Steering or guidance of the wire is achieved by shaping the tip and rotating the proximal end of the wire, thereby transmitting torque along the axis of the core to the flexible tip. This redirects the shaped tip of the Railwire™ allowing selection or avoidance of branch vessels, thus facilitating navigation in tortuous vessels.
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    K Number
    K954622
    Device Name
    IVT 0.014 TRACK OR IVT 0.014 ACCUTRACK
    Date Cleared
    1996-04-29

    (207 days)

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

    BOSTON SCIENTIFIC /INTERNATIONAL TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The IVT 0.014" TRACK is intended to facilitate the navigation and placement of angioplasty and interventional devices through tortuous peripheral and coronary vessels.
    Device Description
    The IVT 0.014" TRACK is constructed from Aermet 100 steel core wire that is distally tapered and fitted with a gold alloy coil. To minimize blood vessel trauma and to facilitate maneuverability, the distal tip is extremely flexible. The core is nominally 0.0136" in diameter. The coil, approximately 1.2" in length with a nominal diameter of 0.0136", is made from a single continuous radiopaque gold alloy wire that has two different wind spacings. The core is inserted into the coil lumen and attached at the distal end utilizing a plasma arc technology that brazes the end of the gold alloy coil to the cylindrical bulb. This special process results in the formation of a gold alloy sphere. The proximal end of the coil is secured to the stainless steel core using a silver alloy solder. The IVT 0.014" TRACK will be manufactured in various lengths ranging from 100 to 300 cms. All IVT 0.014" TRACKs will receive a final parylene (poly-para-xylyene) coating prior to packaging and sterilization. Steering or guidance of the wire is achieved by shaping the tip and rotating the proximal end of the wire, thereby transmitting torque along the axis of the core to the flexible tip. This redirects the shaped tip of the IVT 0.014" TRACK allowing selection or avoidance of branch vessels, thus facilitating navigation in tortuous vessels.
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