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510(k) Data Aggregation

    K Number
    K031903
    Device Name
    RAPIDO CUT-AWAY BLEEDBACK CONTROL VALVE (BBCV), MODEL 7568
    Manufacturer
    GUIDANT CORPORATION
    Date Cleared
    2004-03-03

    (257 days)

    Product Code
    DTZ
    Regulation Number
    870.4350
    Why did this record match?
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    Matched: '870.1270'

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Guidant Bleedback Control Valve is intended for maintaining a seal around The Outdailt Dioodback Ochices with an outside diameter of less than 0.185" in the venous anatomy only, during interventional procedures.
    Device Description
    The RAPIDO™ Cut-Away Bleedback Control Valve is recommended for use during vascular procedures in conjunction with interventional and/or diagnostic devices such as balloon catheters, wires, and pacemaker and defibrillation leads. The RAPIDO™ Cut-Away Bleedback Control Valve has a single adjustable seal that provides control over fluid loss. The Bleedback Control (BBC) seal is a diaphragm seal with a thin membrane across the inside diameter that forms around diagnostic/ interventional devices as they move into and out of the vasculature. This seal provides minimal fluid loss while not restricting device movement. The BBC seal is open when the cap is depressed, and closed with the cap is released. An open BBC seal allows air and fluid to be purged and allows the advancement/withdrawal of diagnostic/ interventional devices. The seal can be locked open by rotating the cap an eighth clockwise turn when the cap is depressed. To release the lock the cap is rotated clockwise an eighth of a turn.
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