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510(k) Data Aggregation

    K Number
    K232055
    Device Name
    Vial Adapter
    Date Cleared
    2023-10-06

    (87 days)

    Product Code
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shanghai Ling Fu Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Vial Adapter is indicated for the transfer and mixing of drugs contained in vials.
    Device Description
    The Vial Adapter consists of luer connector, housing and piercing spike, all of which are made of polycarbonate (PC). The sterile device pierces the elastomeric septum of a drug vial with its integrated piercing spike. The device is then pushed fully onto the drug vial and seats securely around the ferrule of the drug vial utilizing the housing of Vial Adapter. The connector on opposite side of the Vial Adapter is for the connection of a standard Luer needle free syringe for the reconstitution and removal of the contents of the drug vial. The proposed Vial Adapter is available in 13mm, 20mm and 28mm diameter configurations to accommodate respective size of drug vials. The device is intended for use in healthcare facilities or in the home environment by the patient or care-giver to aid and support prescribed treatment and therapy.
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