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510(k) Data Aggregation

    K Number
    K982702
    Device Name
    VENTRIX SUBDURAL TUNNELING PRESSURE MONITORING KIT MODEL NL950-SD
    Manufacturer
    CAMINO NEUROCARE, INC.
    Date Cleared
    1998-09-10

    (38 days)

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

    CAMINO NEUROCARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This ICP catheter is indicated for use on patients that require continuous intracranial pressure monitoring.
    Device Description
    Ventrix™ Subdural Tunneling Pressure Monitoring Kit
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    K Number
    K981846
    Device Name
    PARENCHYMAL BOLT PRESSURE MONITORING KIT
    Manufacturer
    CAMINO NEUROCARE, INC.
    Date Cleared
    1998-08-18

    (84 days)

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

    CAMINO NEUROCARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Parenchymal Bolt Pressure Monitoring Kit is indicated for use on patients that require continuous intracranial pressure monitoring. This device should only be used by a physician or qualified personnel under the direction of a physician. Care must be taken to ensure compliance with the manufacturer's Directions for Use. Prescription Use Only (Per 21 CFR 801.109)
    Device Description
    Parenchymal Bolt Pressure Monitoring Kit
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    K Number
    K962928
    Device Name
    COMBINED INTRACRANIAL PRESSURE-TEMPERATURE SENSING SYSTEM (ICP/)
    Manufacturer
    CAMINO NEUROCARE, INC.
    Date Cleared
    1996-12-20

    (144 days)

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

    CAMINO NEUROCARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Model 110-4BT: Use by a qualified neurosurgeon for direct measurement of intracranial pressure and temperature in the parenchyma. Model 110-4HMT: Use by a qualified neurosurgeon for direct measurement of intracranial pressure and temperature in the ventricles and cerebrospinal fluid drainage. Intended to be used with an external drainage system as indicated by individual manufacturers.
    Device Description
    The Intracranial Pressure-Temperature Monitoring System consists of a catheter and monitor. The catheter is a sterile transducer-tipped pressure monitoring catheter with thermistor and accessory items to be used as a diagnostic tool for rapidly determining and continuously monitoring intracranial pressure and temperature. The Camino catheter has a miniature transducer and thermistor at the distal tip. The pressure transducer is identical to the Camino predicate device. The design eliminates the need for a "fluid-filled system" to carry pressure waves to an external transducer is 4F, fiber optic with a pressure measurement range of -10 to 250 mmHg and a temperature measurement range of 30°C -40°C. The Multi-Parameter Monitor (MPM) is a compact, portable device for use with Camino The MPM measures Intracranial Pressure (ICP). Pressure-Temperature catheters. Intracranial Temperature (ICT) and calculates Cerebral Perfusion Pressure (CPP). The MPM provides a continuous display of the pressure waveform, as well as mean ICP. CPP. temperature or systolic and diastolic values. A continuous record of mean pressure and temperature values over the most recent 24-hour period is stored in memory, and can be displayed on command as a TREND either as the most recent 8 or 24 hour period. An analog output accessory provides a continuous ICP waveform for hard copy documentation or data acquisition. Although the MPM is intended to be a stand alone system, it also conveniently connects to any hospital bedside monitoring system. A builtin rechargeable battery permits monitoring during patient transport. The monitor is equipped with an high ICP alarm. The dimensions are 274 mm x 216 mm x 89 mm and weighs 4.3 Kg.
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