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510(k) Data Aggregation

    K Number
    K182635
    Device Name
    Signal Catheter
    Manufacturer
    Safe Medical Design
    Date Cleared
    2019-01-10

    (108 days)

    Product Code
    EZL
    Regulation Number
    876.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    Safe Medical Design

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Signal Catheter is indicated for urological bladder drainage, with a maximum patient indwelling time of 29 days.
    Device Description
    The Signal Catheter is a 16 French, 2-way silicone Foley catheter, designed to be inserted into the bladder through the urethra to drain urine. The unique signal balloon included in the catheter hub is designed to inflate during excessive pressure in the retention balloon. This typically occurs when the retention balloon is constricted and cannot be inflated at the nominal inflation pressure of the catheter. In this case, the signal balloon inflates to alleviate the fluid and resulting pressure in the retention balloon.
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