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510(k) Data Aggregation

    K Number
    K192991
    Device Name
    Vesco Medical Extension Feeding Set
    Manufacturer
    Vesco Medical LLC
    Date Cleared
    2020-08-03

    (283 days)

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

    Vesco Medical LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Vesco Medical Extension Feeding Sets are intended for use as an extension set to other gastric feeding devices, incorporating safety connectors which may reduce the risk of accidental connection of an IV system, or the enteral system to the IV system.
    Device Description
    The Vesco Medical Extension Feeding Set product line is comprised of a group of enteral tubes that will be used by trained caregivers for the delivery of nutrition and water. The Extension Sets will be used in a hospital or home environment. The Extension Sets will be provided non-sterile and are for single patient use. The Extension Sets will incorporate a male ENFit connector which is compatible with syringes and other devices that have female ENFit connectors. The ENFit connectors are being implemented within enteral feeding devices to eliminate misconnection with non-enteral feeding devices. The Vesco Medical Extension Feeding Sets are non-sterile, single patient use devices consisting of a polyvinylchloride tube, ABS G-button connector, ENFit connector, cap and clamp. The connectors on the proximal end of the extension sets are ENFit ISO 80369-3 compliant. The ENFit connector allows for connections of enteral specific applications while reducing the likelihood of misconnections to non-enteral devices. The G-button connectors are to allow compatibility to the Mic-key and Mini low profile devices.
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