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510(k) Data Aggregation

    K Number
    K101113
    Device Name
    GUARDIAN II NC HEMOSTASIS VALVE
    Manufacturer
    ZERUSA LIMITED
    Date Cleared
    2010-05-21

    (30 days)

    Product Code
    DTL
    Regulation Number
    870.4290
    Why did this record match?
    Applicant Name (Manufacturer) :

    ZERUSA LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Guardian® II NC HV is intended to maintain hemostasis during the use of diagnostic/interventional devices. The device is indicated for maintaining a seal around diagnostic/interventional devices with outside diameters up to 8.0F (2.67 mm or 0.105") during diagnostic/interventional procedures. The guidewire introducer is included to facilitate the guidewire's passage through the Guardian® II NC HV. The Torque Device is included to manipulate the steering of the guidewire within the vascular regions.
    Device Description
    The Zerusa Guardian® II NC Hemostasis Valve is designed to be used as a conduit when interventional devices with diameters up to 8.0F (2.67mm or 0.105") are inserted into the human vascular system. The device has two seals: the low-pressure seal (or wiper seal) and the high-pressure seal. Depressing the cap opens the low-pressure seal, releasing the cap closes the seal. The high-pressure seal is operated by rotating the nut clockwise. Closure of the highpressure seal, which is achieved when the nut can no longer rotate, secures the diagnostic/interventional device in position within the vasculature and also allows for pressure injections up to 150 psi (10 ATM). Included with the Guardian® II NC Hemostasis Valve is a Guidewire Introducer, which is used to facilitate entry of the guidewire into the Guardian® II NC Hemostasis Valve. It consists of an austenitic stainless steel tube connected to a hub constructed of polycarbonate. Also included with the Guardian® II NC HV is a simple Guidewire Torquer which is used to manipulate the steering of a guidewire within the vascular regions.
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    K Number
    K092711
    Device Name
    GUARDIAN II HEMOSTASIS VALVE
    Manufacturer
    ZERUSA LIMITED
    Date Cleared
    2009-10-01

    (28 days)

    Product Code
    DTL
    Regulation Number
    870.4290
    Why did this record match?
    Applicant Name (Manufacturer) :

    ZERUSA LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Guardian™ II HV is intended to maintain hemostasis during the use of diagnostic/interventional device is indicated for maintaining a seal around diagnostic/interventional devices with outside diameters up to 8.0F (2.67 mm or 0.105") during diagnostic/interventional procedures. The guidewire introducer is included to facilitate the guidewire's passage through the Guardian™ II HV. The Torque Device is included to manipulate the steering of the guidewire within the vascular regions.
    Device Description
    The Zerusa Guardian™ II Hemostasis Valve is designed to be used as a conduit when interventional devices with diameters up to 8.0F (2.67mm or 0.105") are inserted into the human vascular system. The device has two seals: the low-pressure seal (or wiper seal) and the highpressure seal. Depressing the cap engages the Quikloc " to open the low-pressure seal, depressing the cap again closes the seal. The high-pressure seal is operated by rotating the nut clockwise. Closure of the high-pressure seal, which is achieved when the nut can no longer rotate, secures the diagnostic/interventional device in position within the vasculature and also allows for pressure injections up to 150 psi (10 ATM). Included with the Guardian™ II Hemostasis Valve is a Guidewire Introducer, which is used to facilitate entry of the guidewire into the Guardian IIM II Hemostasis Valve. It consists of an austenitic stainless steel tube connected to a hub constructed of polycarbonate. Also included with the Guardian™ II HV is a simple Guidewire Torquer which is used to manipulate the steering of a guidewire within the vascular regions.
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    K Number
    K073620
    Device Name
    GUARDIAN HEMOSTASIS VALVE
    Manufacturer
    ZERUSA LIMITED
    Date Cleared
    2008-02-27

    (63 days)

    Product Code
    DTL
    Regulation Number
    870.4290
    Why did this record match?
    Applicant Name (Manufacturer) :

    ZERUSA LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Guardian Hemostasis Valve is intended to maintain hemostasis during the introduction, withdrawal and use of diagnostic/interventional devices during vascular procedures. The Guardian HV is intended to maintain hemostasis during the use of diagnostic/interventional devices. The device is indicated for maintaining a seal around diagnostic/interventional devices with outside diameters up to 8.0F (2.67 mm or 0.105") during diagnostic/interventional procedures. The guidewire introducer is included to facilitate the guidewire's passage through the Guardian HV. The Torque Device is intended to manipulate the steering of the guidewire within the vascular regions.
    Device Description
    The Zerusa Guardian™ Hemostasis Valve is designed to be used as a conduit for which interventional devices with diameters up to 8.0F are inserted into the human vascular system. The device has two seals: the low-pressure seal and the high-pressure seal. Depressing the cap engages the Quikloc TM to open the low-pressure seal, depressing the cap again closes the seal. The high-pressure seal is operated by rotating the nut clockwise. Closure of the high-pressure seal secures the diagnostic/interventional device in position within the vasculature and also allows for pressure injections. The two independently operated seals allow for minimal blood loss during vascular procedures. When the low pressure seal is open, it allows the device to be flushed. During the procedure, the low pressure seal is opened in order to allow the advancement/withdrawal of diagnostic/interventional devices. Included with the Guardian™ Hemostasis Valve is a Guidewire Introducer, which is used to facilitate entry of the guidewire into the hemostasis valve. The Guidewire Introducer has an effective length of 125mm (4.9") and an inside diameter of 0.6mm (or 0.023"). A Guidewire Torquer, intended to manipulate the steering of the guidewire within the vascular regions, is also included.
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    K Number
    K052381
    Device Name
    GUARDIAN HEMOSTASIS VALVE WITH GUIDEWIRE INTRODUCER
    Manufacturer
    ZERUSA LIMITED
    Date Cleared
    2005-11-21

    (83 days)

    Product Code
    DTL
    Regulation Number
    870.4290
    Why did this record match?
    Applicant Name (Manufacturer) :

    ZERUSA LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Guardian HV is intended to maintain hemostasis during the use of diagnostic/interventional devices. The device is indicated for maintaining a seal around diagnostic/interventional devices with outside diameters up to 8.0F (2.67 mm or 0.105") during diagnostic/interventional procedures. The guidewire introducer is included to facilitate the guidewire's passage through the Guardian HV.
    Device Description
    The Zerusa Guardian™ Hemostasis Valve is designed to be used as a conduit for which interventional devices with diameters up to 8.0F are inserted into the human vascular system. The device has two seals: the low-pressure seal and the high-pressure seal. Depressing the cap engages the Quikloc TM to open the low-pressure seal, depressing the cap again closes the seal. The high-pressure seal is operated by rotating the nut clockwise. Closure of the high-pressure seal secures the diagnostic/interventional device in position within the vasculature and also allows for pressure injections. The two independently operated seals allow for minimal blood loss during vascular procedures. When the low pressure seal is open, it allows the device to be flushed. During the procedure, the low pressure seal is opened in order to allow the advancement/withdrawal of diagnostic/interventional devices. Included with the Guardian™ Hemostasis Valve is a Guidewire Introducer, which is used to facilitate entry of the guidewire into the hemostasis valve. The Guidewire Introducer has an effective length of 125mm (4.9") and an inside diameter of 0.6mm (or 0.023").
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