BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Stratus Infusion Catheter

    K Number: K222185 · Decision Apr 13, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    265

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    Basic Information

    Device Name
    Stratus Infusion Catheter
    K Number
    K222185
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1210
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Intervene, Inc.
    Date Received
    July 22, 2022
    Decision Date
    April 13, 2023
    Product Code
    NPG
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    NPG Catheter, Infusion, Syringe