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510(k) Data Aggregation

    K Number
    K221473
    Device Name
    Flowart
    Date Cleared
    2022-09-26

    (129 days)

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

    Asset Medikal Tasarim AS.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Extension sets are for administering fluids from container to a patient's vascular system through a vascular access device. Needleless valve allows the user to add medication into the without the use of a needle. Power Injection Rating and Flowrate (400 psi and 10 mL/sec).
    Device Description
    Not Found
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    K Number
    K221481
    Device Name
    NeutrArt
    Date Cleared
    2022-09-23

    (123 days)

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

    Asset Medikal Tasarim AS.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Extension sets are for administering fluids from container to a patient's vascular system through a vascular access device. Needleless valve allows the user to add medication into the without the use of a needle. Power Injection Rating and Flowrate (400 psi and 10 mL/sec).
    Device Description
    Not Found
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    K Number
    K201872
    Device Name
    NeutrArt
    Date Cleared
    2021-01-05

    (182 days)

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

    Asset Medikal Tasarim AS.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Extension sets are for administering fluids from container to a patient's vascular system through a vascular access device. Stopcocks are intended for use to change the direction of fluids through a tubing set. Needleless valve allows the user to add medication into the without the use of a needle.
    Device Description
    Not Found
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