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510(k) Data Aggregation

    K Number
    K133633
    Device Name
    CHOCOLATE PTCA BOLLOON CATHETER
    Manufacturer
    TRIREME MEDICAL INC
    Date Cleared
    2014-06-02

    (188 days)

    Product Code
    LOX
    Regulation Number
    870.5100
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRIREME MEDICAL INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Chocolate™ PTCA Balloon Dilatation Catheter is indicated for balloon dilatation of the stenotic portion of coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
    Device Description
    The Chocolate PTCA Balloon Catheter is a Rapid Exchange (RX) angioplasty balloon catheter. It consists of a stainless steel hypotube and a nylon shaft, a semi compliant balloon at the distal end of the catheter with a metal constraining structure (CS) and an atraumatic distal tip. Upon inflation, the CS expands with the balloon to a certain diameter; the balloon continues the expansion beyond the CS. Upon deflation, the CS returns to its original shape, and is removed from the vessel along with the balloon catheter. Two Radiopaque markers are added to define the working length of the Chocolate Balloon. The proximal end of the catheter is comprised of a hub used to inflate the balloon that can be connected to a standard inflation device. The catheter will be 140 ±5cm in length, compatible with 0.014" guidewire.
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    K Number
    K122070
    Device Name
    CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE, CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.18 G
    Manufacturer
    TRIREME MEDICAL INC
    Date Cleared
    2012-08-15

    (30 days)

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

    TRIREME MEDICAL INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Chocolate PTA Balloon Catheter is intended for balloon dilatation of lesions in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. NOT for use in the coronary or cerebral vasculature.
    Device Description
    The Chocolate PTA Balloon Catheter is a standard balloon dilatation catheter with a braided shaft and an atraumatic, tapered and beveled tip. The device is compatible with commonly used accessories, including standard 0.014" and 0.018" guidewires and 5F introducer sheath (or 6F guide catheter). Overall catheter lengths are approximately 120 cm to 150cm. All materials are identical to approved PTA Balloon Catheter family of products. The distal end of the catheter has a semi-compliant balloon that expands to known diameters (refer to compliance chart) at specific pressures. The balloon contains radiopaque markers to assist with positioning. The Constraining Structure (CS) has been added to the distal part of the catheter. The shaft is braid reinforced and has a lubricious hydrophilic coating. The proximal end of the device is a common PTA catheter connected to a plastic hub and strain relief. The hub is used to inflate the balloon; the luer connector is compatible with standard inflation devices. The Chocolate Balloon Catheters are supplied sterile and intended for single use only.
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    K Number
    K120677
    Device Name
    CHOCOLATE PTA BALLON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014)
    Manufacturer
    TRIREME MEDICAL INC
    Date Cleared
    2012-03-15

    (9 days)

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

    TRIREME MEDICAL INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Chocolate PTA Balloon Catheter is intended for balloon dilatation of lesions in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. NOT for use in the coronary or cerebral vasculature. The indication for use is the same for all members of the Chocolate PTA Balloon Catheter Family.
    Device Description
    The Chocolate PTA Balloon Catheter is a standard balloon dilatation catheter with a braided shaft and an atraumatic, tapered and beveled tip. The device is compatible with commonly used accessories, including standard 0.014" and 0.018" guidewires and 5F introducer sheath (or 6F guide catheter). Overall catheter lengths are approximately 120 cm to 150cm. All materials are identical to approved PTA Balloon Catheter family of products. The distal end of the catheter has a semi-compliant balloon that expands to known diameters (refer to compliance chart) at specific pressures. The balloon contains radiopaque markers to assist with positioning. The Constraining Structure (CS) has been added to the distal part of the catheter. The shaft is braid reinforced and has a lubricious hydrophilic coating. The proximal end of the device is a common PTA catheter connected to a plastic hub and strain relief. The hub is used to inflate the balloon; the luer connector is compatible with standard inflation devices. The Chocolate Balloon Catheters are supplied sterile and intended for single use only.
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    K Number
    K111544
    Device Name
    GLIDER PTCA BALLOON CATHETER
    Manufacturer
    TRIREME MEDICAL INC
    Date Cleared
    2012-03-02

    (273 days)

    Product Code
    LOX
    Regulation Number
    870.5100
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRIREME MEDICAL INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Glider PTCA Balloon Catheter is indicated for balloon dilatation of the stenotic portion of coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
    Device Description
    The Glider PTCA Balloon Catheter is a torqueable, rapid-exchange, balloon percutaneous transluminal coronary angioplasty (PTCA) catheter. The device is compatible with commonly used accessories including standard 0.014" coronary guide wires and 6F guide catheters. Overall catheter length is approximately 135 cm. The distal end of the catheter has a semi-compliant balloon that expands to known diameters and lengths at specific pressures. The balloon has one or two radiopaque markers to assist with positioning. The braidreinforced shaft and the lubricious hydrophilic coating assist torque transmission. The proximal end of the device is a common PTCA catheter design consisting of a hypotube connected to a plastic hub and strain relief. The hub is used to inflate the balloon and the luer connector is compatible with standard inflation devices. A second lumen within the catheter, intended for guidewire use, extends from the rapid exchange port to the distal tip. The Glider PTCA Balloon Catheter is supplied sterile and intended for single use.
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    K Number
    K101062
    Device Name
    GLIDER PTA BALLOON CATHETER
    Manufacturer
    TRIREME MEDICAL INC
    Date Cleared
    2010-05-12

    (26 days)

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

    TRIREME MEDICAL INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GliderXtreme™ PTA Balloon Catheter is intended for balloon dilatation of lesions in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infrapopliteal, and renal arteries. NOT for use in the coronary or cerebral vasculature.
    Device Description
    The GliderXtreme™ PTA Balloon Catheter is a standard balloon dilatation catheter with a braided shaft and an atraumatic tapered tip. The device is compatible with commonly used accessories, including standard 0.014" and 0.018" guidewires and 5F introducer sheaths (or 6F guide catheters). Overall catheter length is approximately 135 cm. The distal end of the catheter has a semi-compliant balloon that expands to known diameters at specific pressures. The balloon is available in multiple sizes and contains one or two radiopaque markers to assist with positioning. The shaft is braid reinforced and has a lubricious hydrophilic coating. The proximal end of the device is a common PTA catheter design of a hypotube connected to a plastic hub and strain relief. The hub is used to inflate the balloon; the luer connector is compatible with standard inflation devices. A second lumen intended for guidewire use is contained within the catheter. The balloon catheters are available in Rapid Exchange or Over-The-Wire configuration. The GliderXtreme™ PTA Balloon Catheters are supplied sterile and intended for single use only.
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    K Number
    K094019
    Device Name
    GLIDER PTA BALLOON CATHETER
    Manufacturer
    TRIREME MEDICAL INC
    Date Cleared
    2010-02-12

    (45 days)

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

    TRIREME MEDICAL INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Glider™ PTA Balloon Catheter is intended for balloon dilatation of lesions in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. NOT for use in the coronary or cerebral vasculature.
    Device Description
    The Glider™ PTA Balloon Catheter is a standard balloon dilatation catheter with a braided shaft and an atraumatic tapered tip. The device is compatible with commonly used accessories, including standard 0.014" guidewires and 5F introducer sheaths (or 6F guide catheters). Overall catheter length is approximately 135 cm. The distal end of the catheter has a semi-compliant balloon that expands to known diameters at specific pressures. The balloon is available in multiple sizes and contains one or two radiopaque markers to assist with positioning. The shaft is braid reinforced and has a lubricious hydrophilic coating. The proximal end of the device is a common PTA catheter design of a hypotube connected to a plastic hub and strain relief. The hub is used to inflate the balloon; the luer connector is compatible with standard inflation devices. A second lumen within the catheter, intended for guidewire use, extends from the rapid exchange port to the distal tip. The Glider™ PTA Balloon Catheters are supplied sterile and intended for single use.
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