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510(k) Data Aggregation

    K Number
    K053310
    Device Name
    VASCON ROAMER MICROCATHETER
    Manufacturer
    VASCON LLC
    Date Cleared
    2008-07-03

    (948 days)

    Product Code
    KRA
    Regulation Number
    870.1210
    Why did this record match?
    Applicant Name (Manufacturer) :

    VASCON LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VasCon Roamer Microcatheters are indicated for the selective infusion of various diagnostic, therapeutic, and embolic agents into the peripheral, coronary, and neurovasculature.
    Device Description
    The VasCon Roamer Microcatheters are single lumen catheters, incorporating a Pebax body reinforced with stainless steel and platinum wire, a PTFE lubricious inner lumen, and a soft radiopaque tip to reduce potential vessel injury. They are available in French sizes of 2.3/1.9, 2.8/2.3, 3.0/2.8, 2.4/2.0, and 2.8/2.7 and in lengths of 105 cm, 135 cm, and 150 cm. The inside diameters are 0.017, 0.019, 0.021, and 0.027 inches. They have a hydrophilic coating to provide lubricity during use.
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    K Number
    K052004
    Device Name
    VASCON NEUROPATH GUIDING CATHETER
    Manufacturer
    VASCON LLC
    Date Cleared
    2006-01-19

    (178 days)

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

    VASCON LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VasCon NeuroPath™ Guiding Catheter is intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices.
    Device Description
    The VasCon NeuroPath™ Guiding Catheter is a single lumen catheter, incorporating a PEBAX® body reinforced with a stainless steel wire braid. The intermediate segment is also PEBAX® with a stainless steel coil to reduce kinking and to promote improved torque response. The tip is composed of radiopaque 35D PEBAX® to reduce potential vessel injury. They are available in 5Fr and 6Fr, 90 and 100 cm in length, and in a variety of shapes. The technological characteristics are equivalent to the predicate devices.
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    K Number
    K043387
    Device Name
    VASCON POLARIS GUIDING CATHETER
    Manufacturer
    VASCON LLC
    Date Cleared
    2005-02-16

    (69 days)

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

    VASCON LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The guiding catheter is intended for use for intravascular introduction of interventional / diagnostic devices into the coronary or peripheral vascular systems.
    Device Description
    The VasCon Polaris™ Guiding Catheters are single lumen catheters, incorporating a nylon body reinforced with a stainless steel wire braid, a PTFE lubricious inner lumen, and a soft radiopaque tip to reduce potential vessel injury. They are available in 5Fr, 6Fr, 7Fr, and 8Fr, 100 cm in length, and in a variety of shapes. The technological characteristics are equivalent to the predicate device.
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    K Number
    K033633
    Device Name
    VASCON POLARIS GUIDING CATHETER
    Manufacturer
    VASCON LLC
    Date Cleared
    2004-02-18

    (91 days)

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

    VASCON LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The guiding catheter is intended for use for intravascular introduction of interventional / diagnostic devices into the coronary or peripheral vascular systems.
    Device Description
    The VasCon Polaris™ Guiding Catheters are single lumen catheters, incorporating a nylon body reinforced with a stainless steel wire braid, a PTFE lubricious inner lumen, and a soft radiopaque tip to reduce potential vessel injury. They are available in 5Fr, 6Fr, 7Fr, and 8Fr, 100 cm in length, and in a variety of shapes. The technological characteristics are equivalent to the predicate device.
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