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

    Disposable IV catheter

    K Number: K202060 · Decision Jul 23, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    205
    Same Product Code
    503
    Applicant Total
    6
    Review Days
    361

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    Basic Information

    Device Name
    Disposable IV catheter
    K Number
    K202060
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shinva Ande Healthcare Apparatus Co., Ltd.
    Date Received
    July 27, 2020
    Decision Date
    July 23, 2021
    Product Code
    FOZ
    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
    FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

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    Other Clearances by Shinva Ande Healthcare Apparatus Co., Ltd.

    K Number Device Name
    K201460 Closed System Transfer Device
    K220057 Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization
    K211484 Disposable Sterile Syringe with Safety Needle; Disposable Sterile Syringe with Needle; Disposable Sterile Syringe; Disposable Safety Needles
    K193657 Disposable Enteral Feeding Syringe with Enfit Connector
    K162601 Infusion Set for Single Use