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510(k) Data Aggregation

    K Number
    K051599
    Device Name
    NEURORECOVERY, INC. (NRI) COMPREHENSIVE INTRACRANIAL PRESSURE EVALUATION AND RELIEF (CIPER) KIT
    Date Cleared
    2005-07-19

    (33 days)

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

    NEURORECOVERY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Neurorecovery™, Inc., Neurorecovery™ Comprehensive Intracranial Pressure Evaluation and Relief Kit (NRI CIPER™ Kit) is intended for single patient use for the measurement of intracranial pressures (ICP) and drainage of Cerebral Spinal Fluid (CSF). It is intended for short term management of patients with increased intracranial pressure.
    Device Description
    The Neurorecovery" Comprehensive Intracranial Pressure Evaluation and Relief Kit (NRI CIPER™ Kit) is composed of many permanently connected components that incorporate a transducer for connection to an ICP monitoring device. The NRI CIPER™ Kit incorporates components of a cleared intracranial pressure monitoring device, an intracranial pressure transducer, and many components of the Neurorecovery™ Main Valve Assembly. The NRI CIPER™ Kit is designed to be used with the Neurorecovery " Main Valve Assembly. It is provided to the user sterile, non-pyrogenic (fluid path), single use, disposable, and not recommended for reuse of any kind.
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    K Number
    K022638
    Device Name
    NEURORECOVERY VENTRICULAR CATHETER & MAIN VALVE ASSEMBLY KIT
    Date Cleared
    2002-10-31

    (84 days)

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

    NEURORECOVERY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Neurorecovery™, Inc., Neurorecovery" Ventricular Catheter & Main Valve Assembly Kit is designed to be used for external monitoring of intracranial pressure (ICP), cerebrospinal fluid (CSF) sampling, and CSF drainage from the lateral ventricles of the human brain. The Main Valve Assembly is designed to facilitate the monitoring, sampling, clearing, and drainage function in an aseptic manner.
    Device Description
    The Neurorecovery", Inc., Neurorecovery" Ventricular Catheter & Main Valve Assembly Kit consists of legally marketed ventricular catheter, stylet, trocar, valves, tubing, associated connectors, caps, check-valves, needle-free valve, and stopcocks.
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