BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Infusion Sets for Single Use with Needles

    K Number: K221069 · Decision Nov 21, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    424
    Registration Numbers
    424
    Same Product Code
    1173
    Applicant Total
    9
    Review Days
    223

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    Basic Information

    Device Name
    Infusion Sets for Single Use with Needles
    K Number
    K221069
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sichuan Prius Biotechnology Co., Ltd.
    Date Received
    April 12, 2022
    Decision Date
    November 21, 2022
    Product Code
    FPA
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FPA Set, Administration, Intravascular

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    Other Clearances by Sichuan Prius Biotechnology Co., Ltd.

    K Number Device Name
    K221075 Infusion Sets for Single Use
    K221078 Intravenous Needles for Single Use,Safety Intravenous Needles for Single Use
    K221079 Sterile Hypodermic Syringes for Single Use
    K221068 Sterile Hypodermic Syringes for Single Use with Needles
    K221066 Sterile Hypodermic Needles for Single Use
    K221080 Sterile Safety Hypodermic Needles for Single Use
    K221073 Sterile Hypodermic Syringes for Single Use with Safety Needles
    K210908 Surgical Mask