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510(k) Data Aggregation

    K Number
    K981061
    Device Name
    INTRAVASCULAR RETRIEVAL DEVICE
    Manufacturer
    MED INSTITUTE, INC.
    Date Cleared
    1998-05-26

    (64 days)

    Product Code
    GCC, DRE, DXE
    Regulation Number
    878.4200
    Why did this record match?
    Product Code :

    GCC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Byrd Dilator Sheath Set is intended for use in patients requiring the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters and foreign objects. The Byrd Stainless Steel Dilator Sheath is intended for use in patients requiring the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters and foreign objects. The Byrd WORK STATION™ is intended for use in patients requiring the percutaneous retrieval of cardiac leads, indwelling catheters, fragments of catheter tubing or wire guides, and other foreign objects. The Byrd Telescoping Stainless Steel Dilator Sheath Set is intended for use in patients requiring the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters and foreign objects. The NEEDLE'S EYE™ Snare is intended for use in patients requiring the percutaneous retrieval of indwelling catheters, cardiac leads, fragments of catheter tubing or wire guides, and other foreign objects.
    Device Description
    The devices consist of sheaths and snares intended for use in patients requiring the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters, and foreign objects and/or in patients requiring the percutaneous retrieval of cardiac leads, indwelling catheters, fragments of catheter tubing or wire guides, and other foreign objects.
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