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

    FLOWER INFUSION CATHETER MODEL F-25/50, F-60/70

    K Number: K955525 · Decision Aug 8, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    147
    Registration Numbers
    147
    Same Product Code
    174
    Applicant Total
    2
    Review Days
    248

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    Basic Information

    Device Name
    FLOWER INFUSION CATHETER MODEL F-25/50, F-60/70
    K Number
    K955525
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1210
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Interventional Innovations Corp.
    Date Received
    December 4, 1995
    Decision Date
    August 8, 1996
    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 Interventional Innovations Corp.

    K Number Device Name
    K964154 SEGUE INFUSION CATHETER