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510(k) Data Aggregation

    K Number
    K020430
    Device Name
    DIATEK CONNECTOR ASSEMBLY REPLACEMENT KIT (CARK)
    Manufacturer
    DIATEK, INC.
    Date Cleared
    2002-05-09

    (90 days)

    Product Code
    NFK
    Regulation Number
    876.5540
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIATEK, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Diatek Connector Assembly Replacement Kit is to be used for replacing the original connector assembly on a Diatek Cannon-Cath Dialysis Catheter if the connector assembly becomes damaged or dysfunctional. This prevents the patient from requiring additional surgery for catheter removal and replacement. The Connector Assembly Replacement Kit is intended for use in any patient who has a previously implanted Diatek Cannon-Cath implanted.
    Device Description
    The Diatek Connector Assembly Replacement Kit consists of a Cannon-Cath connector assembly and components needed to remove the previously implanted connector assembly and attach the new connector assembly to the previously implanted dialysis catheter.
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    K Number
    K010399
    Device Name
    DIATEK CANNON-CATH #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC, CC2800PC, CC3200PC(32 CM), CC3200PC(36 CM)
    Manufacturer
    DIATEK, INC.
    Date Cleared
    2001-08-14

    (186 days)

    Product Code
    MSD
    Regulation Number
    876.5540
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIATEK, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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