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

    BOBBY Balloon Guide Catheter

    K Number: K261549 · Decision Jun 9, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    72
    Registration Numbers
    72
    Same Product Code
    91
    Applicant Total
    1
    Review Days
    29

    Basic Information

    Device Name
    BOBBY Balloon Guide Catheter
    K Number
    K261549
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    MicroVention, Inc., d/b/a Terumo Neuro
    Date Received
    May 11, 2026
    Decision Date
    June 9, 2026
    Product Code
    QJP
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QJP Catheter, Percutaneous, Neurovasculature

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (QJP), ordered by most recent decision date.

    Zenith Distal Access Long Sheath

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SAYA 86 Radial Access Guide Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BosCATH Support Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Next Generation 088 Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PATH BGC

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Radical 6F Access Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all