BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇹 Italy

    Deltaven Fast Flash Closed I.V. Catheter Systems

    K Number: K200373 · Decision Aug 26, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    205
    Same Product Code
    503
    Applicant Total
    3
    Review Days
    194

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    Basic Information

    Device Name
    Deltaven Fast Flash Closed I.V. Catheter Systems
    K Number
    K200373
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Delta Med Spa
    Date Received
    February 14, 2020
    Decision Date
    August 26, 2020
    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 Delta Med Spa

    K Number Device Name
    K171530 Deltaven XiV Max, Deltaven XiV Max FF
    K140175 INTRAVASCULAR ADMINISTRATION SET