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

    Bendit2.7 Steerable Microcatheter

    K Number: K190126 · Decision Aug 22, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    210
    Registration Numbers
    211
    Same Product Code
    499
    Applicant Total
    4
    Review Days
    206

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    Basic Information

    Device Name
    Bendit2.7 Steerable Microcatheter
    K Number
    K190126
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bend IT Technologies, Ltd.
    Date Received
    January 28, 2019
    Decision Date
    August 22, 2019
    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 Bend IT Technologies, Ltd.

    K Number Device Name
    K252213 Bendit17 Microcatheter
    K203842 Bendit21 Microcatheter
    K200582 Bendit2.7 Steerable Microcatheter