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510(k) Data Aggregation

    K Number
    K081773
    Device Name
    OSV II
    Manufacturer
    INTEGRA NEUROSCIENCES IMPLANTS S.A.
    Date Cleared
    2008-11-06

    (136 days)

    Product Code
    JXG
    Regulation Number
    882.5550
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTEGRA NEUROSCIENCES IMPLANTS S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OSV II is an implantable system used in the treatment of patients with hydrocephalus, to shunt CSF from the ventricles to the peritoneal cavity or other appropriate drainage site such as the heart's right atrium.
    Device Description
    The OSV II is designed to shunt cerebrospinal fluid (CSF) from the ventricles of the brain to an appropriate drainage site, such as the atrium of the heart or the peritoneal cavity. Unlike conventional valves, it is a variable resistance valve which maintains a drainage rate constant within the physiological range (for the specified populations and disorders) of intracranial pressure. The principle of operation consists of a flow restricting diaphragm, a seat, and a notched pin. The diaphragm, held between two polysulfone parts of the casing, reacts to variations in pressure. A synthetic ruby seat is inserted into the center of the diaphragm. As pressure varies, the clearance between the seat and the pin increases or decreases depending on seat movement along the pin.
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    K Number
    K082250
    Device Name
    AURAGEN CORTICAL SURFACE ELECTRODES
    Manufacturer
    INTEGRA NEUROSCIENCES
    Date Cleared
    2008-10-10

    (63 days)

    Product Code
    GYC
    Regulation Number
    882.1310
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTEGRA NEUROSCIENCES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Auragen™ Cortical Surface Electrodes are intended for the intraoperative recording of EEG signals at the cortical surface of the brain.
    Device Description
    The cortical surface electrodes are designed for intraoperative monitoring of cortical electrical activity in order to define the location of epileptogenic foci. They are placed on the exposed cortical surface or inserted into the subdural space to contact the cortical surface. Cortical electrodes vary in size according to the number of contacts. The type of cortical electrode used is dependent on the procedure and the size of area being tested. The Auragen Cortical Electrodes are available with platinum/iridium contacts, with 4 to 64 contacts. The electrodes are connected to Integra recording cables themselves connected to the hospital EEG recording equipment.
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    K Number
    K050720
    Device Name
    NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING KIT/SYSTEM, MODELS NS-P, NS-100
    Manufacturer
    INTEGRA NEUROSCIENCES
    Date Cleared
    2005-05-11

    (51 days)

    Product Code
    GWM
    Regulation Number
    882.1620
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTEGRA NEUROSCIENCES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NeuroSensor® Cerebral Blood Flow and Intracranial Pressure Monitoring System is intended for use by a qualified clinician in monitoring cerebral blood flow in patients at risk of cerebral ischemia, and for the direct monitoring of intracranial pressure in intraparenchymal applications.
    Device Description
    Each NeuroSensor® system consists of a single-use probe and introducer for the continuous real-time measurement of Cerebral Blood Flow (CBF) and Intracranial Pressure (ICP), and a monitor for the display and storage of these measured parameters and the computation and display of derived parameters. The NeuroSensor® monitor can be connected to a hospital bedside monitor for display of ICP. The NeuroSensor® monitor can accept Systemic Arterial Pressure (SAP) data from a hospital bedside monitor, and can use this data and the measured CBF and ICP to compute Cerebral Perfusion Pressure (CPP) and Cerebrovascular Resistance (CVR).
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    K Number
    K042558
    Device Name
    EQUI-FLOW VALVE AND SHUNT SYSTEM
    Manufacturer
    INTEGRA NEUROSCIENCES IMPLANTS S.A.
    Date Cleared
    2004-10-06

    (15 days)

    Product Code
    JXG
    Regulation Number
    882.5550
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTEGRA NEUROSCIENCES IMPLANTS S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Equi-Flow™ Valve and Shunt Systems are used in the treatment of patients with hydrocephalus. The device is designed to shunt cerebrospinal fluid from the ventricles of the brain to an appropriate drainage site, such as the atrium of the heart or the peritoneal cavity. The Equi-Flow™ Valve is indicated in patients where excessive reduction of intraventricular pressure or volume may be caused by the siphoning effect of hydrostatic pressure in the Distal Catheter of the shunt system.
    Device Description
    The Integra NeuroSciences Equi-Flow™ Valve is a multi-function membrane valve incorporating a normally open Siphon Limiting Device, occluders, and integrant valving connectors. It is used in treatment of patients with hydrocephalus when shunting cerebrospinal fluid (CSF) from ventricles of the brain. It incorporates a central reservoir for pumping and injection, proximal and distal occluders, and a fully flexible profile. The Siphon Limiting Device limits the siphon effect in the shunt system by closing when exposed to a negative Hydrostatic pressure (often caused by the patient sitting or standing). The Equi-Flow Valve incorporates a central reservoir for pumping and injection, proximal and distal occluders, and a fully flexible profile. The Equi-Flow Valve design includes a flat silicone membrane, which provides resistance to CSF flow. The flat silicone membrane seats on a conical polypropylene base which is integral to the Siphon Limiting Device. This base is integral to a rigid outlet port. The design allows for accurate and precise regulation of CSF flow due to its structural integrity. The flat silicone membrane also prevents retrograde flow of CSF. The Equi-Flow valve is available in two sizes: Regular and Small. Both sizes are available in five pressure/flow characteristics ranges: Low/Low, Low, Low/Medium, Medium and High.
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    K Number
    K042277
    Device Name
    SELECTOR QUANTUM ULTRASONIC ASPIRATOR SYSTEM
    Manufacturer
    INTEGRA NEUROSCIENCES, LTD.
    Date Cleared
    2004-09-29

    (37 days)

    Product Code
    LFL
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTEGRA NEUROSCIENCES, LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SELECTOR® Quantum Ultrasonic Aspirator System is indicated for use in surgical procedures where fragmentation emulsification and aspiration of soft tissue is desirable, including Neurosurgery, Gastrointestinal and affiliated organ surgery, Urological surgery, Plastic and Reconstructive surgery, General surgery, Orthopedic surgery, Gynecological surgery, Thoracic surgery, Laparoscopic surgery and Thoracoscopic surgery.
    Device Description
    The SELECTOR® Ouantum Ultrasonic Aspirator System dissects and fragments soft tissue and leaves essential elastic structures such as nerves and blood vessels relatively undamaged. It is particularly useful for the ablation of unwanted tissue adjacent or attached to vital structures. The system consists of a Console, which provides control and display of aspiration, irrigation and ultrasonic power, and one or more Handpieces for selective tissue removal at the surgical site. The handpieces have a titanium tip and silicone irrigation flue. The tips are interchangeable which allows the surgeon to use the same handpiece for different applications. The required settings on the Console are selected by operation of up-down controls on the front panel. The Console provides power to the footswitch, which has two controls. One pedal provides proportional control of ultrasonic power, and the other the flow of irrigation fluid. An accessory Service Module may be used to provide a convenient source of suction and waste collection. A range of handpieces are connected to the console, both electrically and by a disposable sterile tubing kit which delivers sterile saline for irrigation, and removes aspirated waste matter. A special version of the Selector system will be available for use within an MRI suite. All handpieces may be sterilized by steam autoclaving or by Ethylene Oxide.
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    K Number
    K042192
    Device Name
    LOW FLOW OSV II HYDROCEPHALUS VALVE
    Manufacturer
    INTEGRA NEUROSCIENCES IMPLANTS S.A.
    Date Cleared
    2004-09-02

    (21 days)

    Product Code
    JXG
    Regulation Number
    882.5550
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTEGRA NEUROSCIENCES IMPLANTS S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Low Flow OSV II Hydrocephalus Valve is an implantable system used in the treatment of patients with hydrocephalus, to shunt CSF from the ventricles to the peritoneal cavity or other appropriate drainage site such as the heart's right atrium.
    Device Description
    The Precision Flow OSV II and the modified Low Flow OSV II hydrocephalus valve systems are implantable devices for controlled cerebrospinal fluid drainage from the ventricles to the peritoneal cavity or other appropriate drainage site such as the heart's right atrium. Unlike conventional valves, they are variable resistance valves which maintain a drainage rate constant within the physiological range (for the specified populations and disorders) of intracranial pressure.
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    K Number
    K040201
    Device Name
    MODIFICATION TO BURR HOLE VALVE AND SHUNT SYSTEM
    Manufacturer
    INTEGRA NEUROSCIENCES IMPLANTS S.A.
    Date Cleared
    2004-02-26

    (28 days)

    Product Code
    JXG
    Regulation Number
    882.5550
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTEGRA NEUROSCIENCES IMPLANTS S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Integra NeuroSciences Burr Hole Valve and Shunt System is used in treatment of patients with hydrocephalus. The Burr Hole Valve is a component of a system designed to shunt cerebrospinal fluid from the ventricles of the brain to an appropriate drainage site such as the atrium of the heart or to the peritoneal cavity.
    Device Description
    The Integra NeuroSciences Burr Hole Valve incorporates a membrane valve with integral connectors and domed reservoir to fit into a formal burr hole. It is used in treatment of patients with hydrocephalus when shunting cerebrospinal fluid (CSF) from ventricles of the brain. The Burr Hole design includes a flat silicone membrane, which provides resistance to CSF flow. The silicone membrane scats on a conical polypropylene base. This base is int4egral to a rigid outlet port. The design allows for accurate and precise regulation of CSF flow due to its structural integrity. The flat silicone membrane also prevents retrograde flow of CSF. The Burr Hole valve is available in two sizes designed to fit a 12mm or 16mm formal burr Both sizes are available in three (3) pressure/Now characteristics ranges: low, hole. medium, and high.
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    K Number
    K033698
    Device Name
    CONTOUR-FLEX VALVE AND SHUNT SYSTEM
    Manufacturer
    INTEGRA NEUROSCIENCES IMPLANTS S.A.
    Date Cleared
    2003-12-17

    (22 days)

    Product Code
    JXG
    Regulation Number
    882.5550
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTEGRA NEUROSCIENCES IMPLANTS S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Integra NeuroSciences Contour-Flex Valve and Shunt System is used in treatment of patients with hydrocephalus. It is a component of a system designed to shunt cerebrospinal fluid from the ventricles of the brain to an appropriate drainage site such as the atrium of the heart or to the peritoneal cavity.
    Device Description
    The Integra NeuroSciences Contour-Flex™ Valve is a multi-function membrane valve with occluders and integral connectors. It is used in treatment of patients with hydrocephalus when shunting cerebrospinal fluid (CSF) from ventricles of the bram. It incorporates a central reservoir for pumping and injection, proximal and distal occluders, and a fully flexible profile. The Contour-Flex Valve design includes a flat siliconc membrane, which provides resistance to CSF flow. The flat silicone membrane seats on a conical polypropylene base. This base is integral to a rigid outlet port. The design allows for accurate and precise regulation of CSF flow due to its structural integrity. The flat silicone membrane also prevents retrograde flow of CSF. The Contour-Flex valve is available in two s izes: R egular a nd S mall. B oth s izes a re a vailable in 3 pressure/flow c haracteristics ranges: low, medium, and high
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    K Number
    K032817
    Device Name
    EXTERNAL DRAINAGE SET
    Manufacturer
    INTEGRA NEUROSCIENCES IMPLANTS S.A.
    Date Cleared
    2003-10-06

    (26 days)

    Product Code
    JXG
    Regulation Number
    882.5550
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTEGRA NEUROSCIENCES IMPLANTS S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The External Drainage Sets are intended for cerebrospinal fluid (CSF) drainage, sampling and collection.
    Device Description
    The External Drainage Set is designed for cerebrospinal fluid (CSF) drainage, sampling and collection. The system connects to a ventricular or lumbar catheter via a Luer connection to a patient line. The graduated cylinder of the External Drainage Set is attached to an IV pole and may be moved up and down to change positioning of the graduated cylinder by using the Velcro straps. CSF can be collected and measured in the graduated cylinder and subsequently emptied to the drainage bag by opening the stopcock placed in-line between the graduated cylinder and the drainage bag. A hydrophobic vent filter is included in the graduated cylinder cap of the External Drainage Set. This vent filter allows air to enter the graduated cylinder to facilitate drainage from the graduated cylinder to the drainage bag while protecting the system from contamination.
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    K Number
    K021989
    Device Name
    SELECTOR INTEGRA ULTRASONIC SURGICAL ASPIRATOR, MODEL OM 1530000M3
    Manufacturer
    INTEGRA NEUROSCIENCES
    Date Cleared
    2002-09-13

    (87 days)

    Product Code
    LFL
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTEGRA NEUROSCIENCES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SELECTOR® Integra Ultrasonic Aspirator System is indicated for use in surgical procedures where fragmentation emulsification and aspiration of soft tissue is desirable, including Neurosurgery, Gastrointestinal and affiliated organ surgery, Urological surgery, Plastic and Reconstructive surgery, General surgery, Orthopedic surgery, Gynecological surgery, Thoracic surgery, Laparoscopic surgery and Thoracoscopic surgery.
    Device Description
    The Selector Ultrasonic Surgical Aspirator System dissects and fragments soft tissue and leaves essential elastic structures such as nerves and blood vessels relatively undamaged. It is particularly useful for the ablation of unwanted tissue adjacent or attached to vital structures. The system consists of a Console, which provides control and display of aspiration, irrigation and ultrasonic power, and one or more Handpieces for selective tissue removal at the surgical site. The Handpieces have a titanium tip and irrigation flue. The required settings on the console are selected by operation of up-down controls on the membrane switch front panel. The console provides power to the footswitch, which has two controls. One pedal provides proportional control of ultrasonic power, and the other the flow of irrigation fluid. An accessory Service Module may be used to provide a convenient source of suction and waste collection. A range of Handpieces are connected to the console, both electrically and by a disposable sterile tubing kit which delivers sterile saline for irrigation, and removes aspirated waste matter. A special version of the Selector system is available for use within an MRI suite. All handpieces can be sterilized by steam autoclaving or by Ethylene Oxide. A large number of these are in routine use.
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