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510(k) Data Aggregation

    K Number
    K232831
    Device Name
    Quiver Aspiration Pump
    Date Cleared
    2024-02-22

    (162 days)

    Product Code
    Regulation Number
    878.4780
    Why did this record match?
    Applicant Name (Manufacturer) :

    Anoxia Medical Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Quiver Aspiration Pump is intended for general suction use in hospitals or clinics.
    Device Description
    The Quiver Aspiration Pump is designed to provide general suction for use in hospitals or clinics. The Quiver Aspiration Pump provides battery powered suction for the removal or aspiration of fluids and debris. The Pump is a portable, single-use, non-sterile and provides up to -29inHg vacuum pressure. For sterile field use, the pump is provided with sterile accessory tubing and a sterile flow control switch. The accessories are also single-use and disposable. The Quiver Aspiration Pump system is comprised of the following: - Quiver Aspiration Pump: The Quiver Aspiration Pump is battery-operated (18VDC, nonrechargeable), has an ON/OFF button, and serves as a vacuum source for aspirating and suctioning for general use applications. Within the pump assembly, the DC motor drives a diaphragm pump that provides high vacuum suction and flows in one direction for material removal only. Affixed to the pump is a waste collection bag (500mL) that collects and contains all fluids and materials that were aspirated. The aspiration pump is non-patient contacting. Sterile aspiration tubing accessories are provided with the pump to facilitate connection to other suction devices with a standard medical luer connection. The inline flow control switch allows the user to initiate and terminate the suction from the distal end of the tubing. The entire pump assembly is disposable following standard biohazard handling procedures. - Accessories: Included in the pump package are the aspiration tubing and the inline control flow switch. Both accessories are individually packaged in sterile pouches. These components are finished sterile devices manufactured and sterilized by Merit Medical (South Jordan, UT) and sold to Anoxia as finished medical devices. The aspiration tubing has a standard female luer fitting. The inline flow control switch is connected to the distal end of the tubing. The tubing is 72 inches long to allow for use within a sterile field if necessary for general suction applications. The flow switch has a standard male luer that can be connected to other devices used for suction that have the same standard medical luer. The two accessories and the pump are packaged in a carton box.
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