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

    Instylla Microcatheter 1.2

    K Number: K210808 · Decision Apr 15, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    147
    Registration Numbers
    147
    Same Product Code
    174
    Applicant Total
    10
    Review Days
    29

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    Basic Information

    Device Name
    Instylla Microcatheter 1.2
    K Number
    K210808
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1210
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Instylla, Inc.
    Date Received
    March 17, 2021
    Decision Date
    April 15, 2021
    Product Code
    KRA
    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
    KRA Catheter, Continuous Flush

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    Other Clearances by Instylla, Inc.

    K Number Device Name
    K261610 Verge™ Microcatheter
    K253769 Instylla Delivery Kit
    K253677 Tembo Embolic System
    K240873 TEMBO Embolic System
    K213632 Instylla Delivery Kit
    K202544 Instylla Delivery Kit
    K200744 Instylla Microcatheter
    K191659 Instylla Delivery Kit
    K191731 Instylla Microcatheter