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510(k) Data Aggregation

    K Number
    K061143
    Device Name
    ROBERTSITE STOPCOCK
    Manufacturer
    HALKEY-ROBERTS CORP.
    Date Cleared
    2006-05-10

    (15 days)

    Product Code
    FMG
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    HALKEY-ROBERTS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Robertsite® stopcock provides a needleless access port and multi-directional flow during fluid administration to a patient's vascular system.
    Device Description
    The device is a single use 4-way stopcock with one Robertsite® needleless injection port. The major device materials are polycarbonate and silicone.
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    K Number
    K040634
    Device Name
    ROBERTSITE VIAL ADAPTER, MODEL 245700021
    Manufacturer
    HALKEY-ROBERTS CORP.
    Date Cleared
    2004-03-23

    (13 days)

    Product Code
    LHI
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    HALKEY-ROBERTS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Robertsite* Vial Adapter is indicated to allow multiple needleless access to injection medication vials for transfer or withdrawal of fluids from the vial. Robertsite* Vial Adapter is indicated to allow multiple needleless access to an injection medication vial for the purpose of facilitating the withdrawal or addition of drugs/solutions from or to the vial.
    Device Description
    Sterile single use device.
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