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510(k) Data Aggregation

    K Number
    K053188
    Device Name
    REPROCESSED BALOON INFLATION DEVICE
    Manufacturer
    STERILMED, INC.
    Date Cleared
    2006-05-04

    (170 days)

    Product Code
    NKU
    Regulation Number
    870.1650
    Why did this record match?
    Product Code :

    NKU

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The reprocessed Balloon Inflation Device is intended for use with balloon dilatation catheters to create and monitor pressure in the balloon and to deflate the balloon.
    Device Description
    The Reprocessed Balloon Inflation Device consists of a threaded plunger, locking mechanism, pressure gauge, Device and connecting tube. A finger latch controls the locking mechanism on the device. When the device is unlocked the threaded plunger may be advanced or withdrawn. Locking of the device allows for generation and monitoring of pressure in atmospheres (atm) and pounds per square inch (psi).
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