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

    Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter

    K Number: K202049 · Decision Sep 7, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    73
    Applicant Total
    12
    Review Days
    410

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    Basic Information

    Device Name
    Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter
    K Number
    K202049
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.5150
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Applied Medical Resources Corporation
    Date Received
    July 24, 2020
    Decision Date
    September 7, 2021
    Product Code
    DXE
    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
    DXE Catheter, Embolectomy

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