LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K123751
    Device Name
    LOFRIC SENSE
    Manufacturer
    WELLSPECT HEALTHCARE
    Date Cleared
    2013-02-28

    (84 days)

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

    WELLSPECT HEALTHCARE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Intermittent urinary catheterization.
    Device Description
    LoFric® Sense™ is a single-use catheter designed as an intermittent pathway for drainage of the bladder. The catheters are available in one length with a Nelaton (straight) tip and a variety of diameters to accommodate individual anatomy. Each catheter is packaged with a water packet that is to be broken immediately before use in order to soak the tubing.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1