Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K173533
    Device Name
    Duette 100% Silicone Dual-Balloon, Temperature-Sensing Catheter
    Date Cleared
    2018-03-29

    (134 days)

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

    Poiesis Medical, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Poiesis Medical Duette™ 100% Silicone Dual-Balloon, Temperature Sensing Catheter is intended for use in the drainage/collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgical or post-surgical intervals.
    Device Description
    The Poiesis Medical Duette™ 100% Silicone Dual-Balloon, Temperature Sensing Catheter is intended for use in the drainage/collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgical or post-surgical intervals. The device is a Foley Catheter that is used for simultaneous monitoring of the body core temperature during surgical intervals. It is composed of 100% silicone. The Duette™ 100% Silicone Dual-Balloon, Temperature Sensing Catheter comes in two sizes (16Fr and 18Fr). The catheters consist of a shaft with eyelets near the tip, two (2) balloons, drainage funnel and two (2) inflation arms with cap and valve. The eyelets allow for drainage of urine from the tip of the catheter through the drainage lumen. When inflated the balloons retains the catheter within the bladder. There are four (4) lumens in each catheter: one (1) for urine drainage, two (2) for individual balloon inflation/deflation and one (1) for the temperature sensing capability. The device is EtO sterilized and is a single-use device.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1