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

    Wallaby 017 Micro Catheter

    K Number: K223139 · Decision Apr 25, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    147
    Registration Numbers
    147
    Same Product Code
    174
    Applicant Total
    5
    Review Days
    203

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    Basic Information

    Device Name
    Wallaby 017 Micro Catheter
    K Number
    K223139
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1210
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Wallaby Medical
    Date Received
    October 4, 2022
    Decision Date
    April 25, 2023
    Product Code
    KRA
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KRA Catheter, Continuous Flush

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