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    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    Drakon and Sequre Microcatheters

    K Number: K203487 · Decision Dec 11, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    210
    Registration Numbers
    211
    Same Product Code
    499
    Applicant Total
    3
    Review Days
    14

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    Basic Information

    Device Name
    Drakon and Sequre Microcatheters
    K Number
    K203487
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Accurate Medical Therapeutics, Ltd.
    Date Received
    November 27, 2020
    Decision Date
    December 11, 2020
    Product Code
    DQO
    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
    DQO Catheter, Intravascular, Diagnostic

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    Other Clearances by Accurate Medical Therapeutics, Ltd.

    K Number Device Name
    K202797 Drakon and Sequre Microcatheters
    K173430 SeQure® NF and SeQure® Microcatheters