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510(k) Data Aggregation

    K Number
    K161731
    Device Name
    Cleveland Multiport Ventricular Catheter Set
    Manufacturer
    Parker Hannifin Corp.
    Date Cleared
    2017-03-27

    (277 days)

    Product Code
    HCA
    Regulation Number
    882.4100
    Why did this record match?
    Applicant Name (Manufacturer) :

    Parker Hannifin Corp.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cleveland Multiport Ventricular Catheter Set is indicated for gaining access to the ventricles of the brain for the removal of cerebrospinal fluid (CSF) or for injecting Cytarabine.
    Device Description
    The Cleveland Multiport Ventricular Catheter contains a main or central lumen for the insertion stylet which is surrounded by four minor lumens (equally spaced) that contain the microcatheters. The catheter includes a ribbed distal tip, a housing for locking the insertion stylet, and proximal male Luer fittings at the end of each micro-catheter. The ribbed distal tip of the main catheter allows the micro-catheters to retract into the main catheter, by stretching the catheter when the insertion stylet is fully inserted and locked. This stretched state allows the catheter tip outside diameter to reduce slightly for atraumatic insertion into the ventricles of the brain. Once the insertion stylet is removed the catheter tip returns to its relaxed state (larger outside diameter) and the micro-catheters deploy. The enlarged tip aids in backflow prevention during injection of fluids. The distal Luer fittings allow for connectivity to a standard syringe or infusion pumps for removal of CSF and/or infusion. The biocompatible metal insertion stylet provides temporary rigidity to the distal portion of the device during catheter insertion and is removed after placement. The Cleveland Multiport Ventricular Catheter has no software, power sources, or radiation emitting components.
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