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

    PATH BGC

    K Number: K260938 · Decision Apr 15, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    72
    Registration Numbers
    72
    Same Product Code
    91
    Applicant Total
    2
    Review Days
    26

    Basic Information

    Device Name
    PATH BGC
    K Number
    K260938
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Crossroads Neurovascular, Inc.
    Date Received
    March 20, 2026
    Decision Date
    April 15, 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.

    BOBBY Balloon Guide Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    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

    Radical 6F Access Catheter

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

    Other Clearances by Crossroads Neurovascular, Inc.

    K Number Device Name
    K242392 PATH BGC