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

    Bullfrog Micro-Infusion Device

    K Number: K161402 · Decision Aug 18, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    147
    Registration Numbers
    147
    Same Product Code
    174
    Applicant Total
    5
    Review Days
    90

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    Basic Information

    Device Name
    Bullfrog Micro-Infusion Device
    K Number
    K161402
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1210
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mercator Medsystems, Inc.
    Date Received
    May 20, 2016
    Decision Date
    August 18, 2016
    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 Mercator Medsystems, Inc.

    K Number Device Name
    K210339 Bullfrog Micro-Infusion Device
    K153501 Bullfrog Micro-Infusion Device
    K131401 BLOWFISH TRANSBRONCHIAL MICRO-INFUSION CATHETER
    K062752 MERCATOR MICROSYRINGE II INFUSION CATHETER