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510(k) Data Aggregation

    K Number
    K223890
    Device Name
    NAJA Gastrointestinal Catheter
    Manufacturer
    Date Cleared
    2023-06-16

    (171 days)

    Product Code
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    Chess Medical Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The NAJA Gastrointestinal Balloon Catheter is intended to administer contrast medium to the small intestine.
    Device Description
    The NAJA Gastrointestinal Balloon Catheter ("NAJA device") is a single-use, single-operator, over the-wire, double balloon catheter that is compatible with 0.035" guidewires. The device is introduced orally and designed for temporary occlusion of the gastrointestinal (GI) lumen (small intestine), allowing infusion of fluids for enteroclysis studies (i.e., imaging tests of the small intestine). The device is designed to fit inside the working channel of a gastroscope and reaches its intended location by tracking over a 0.035" guidewire. The NAJA device features a separate hub connector that is attachable and detachable from the catheter. This feature allows removal of the gastroscope from the catheter once the balloons are in the correct location and before the hub connector is attached for balloon inflation and infusion of fluids into the GI lumen. The hub connector is supplied with 1-way stopcocks on the inflation and infusion ports. The NAJA device is also provided with a 30cc syringe for balloon inflation and infusion of fluids. The balloons are inflated independently using air.
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