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510(k) Data Aggregation

    K Number
    K982565
    Device Name
    EASY TRANS TIP
    Manufacturer
    CARL SCHUH
    Date Cleared
    1998-09-22

    (61 days)

    Product Code
    KXO
    Regulation Number
    884.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARL SCHUH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This intrauterine pressure monitoring catheter (IUPC) is for use on patients requiring intrapartum intrauterine pressure monitoring. Additionally it may be used for amniofusion and of Amniotic fluid sampling
    Device Description
    This disposable device is a catheter with a pressure transducer located at the distal tip to monitor the intrauterine pressure. The sensor/transducer is a thick film/ceramic strain gage connected via 4 leads to a connector in proximal end. This end connector interfaces with a reusable cable designed for the proper connection to the monitor in use. The IUPC has a separate fluid infusion and sampling lumen with three holes near the distal end that terminates at the proximal end with a luer fitting/cap. Incorporated in the connector housing at the proximal end is a switch for electronic zeroing of the transducer. This switch can also be used for periodic rezeroing of the system during use without the need for removal and replacement of the catheter. The distal end of the catheter holding the sensor is rounded and blunt while the catheter is soft, flexible polyurethane. The introducer, is designed to ease the insertion of the flexible catheter and is of a split sheath design for easy removal from the catheter after insertion. A Velcro attachment devise is supplied to attach the catheter firmly in place on the patients thigh to prevent inadvertent slippage or dislodgment during use.
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