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510(k) Data Aggregation

    K Number
    K152261
    Device Name
    PICC Tip Positioning Aid
    Manufacturer
    NOSTIX LLC
    Date Cleared
    2015-10-21

    (71 days)

    Product Code
    LJS
    Regulation Number
    880.5970
    Why did this record match?
    Applicant Name (Manufacturer) :

    NOSTIX LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PICC Tip Positioning Aid is indicated for the positioning of Peripherally Inserted Central Catheters (PICC) in adult patients. It provides real-time catheter tip location by using the patient's cardiac electrical activity. The PICC Tip Positioning Aid is indicated for use as an alternative method to chest x-ray or fluoroscopy confirmation of PICC tip placement in adult patients.
    Device Description
    The PICC Tip Positioning Aid includes a standalone Monitor containing software, battery and power cord accompanied by an ECG Patient Cable, a Remote Control Cable, probe cover and ECG Clip Cable.
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