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

    Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable

    K Number: K232852 · Decision Oct 12, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    19
    Applicant Total
    2
    Review Days
    28

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    Basic Information

    Device Name
    Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable
    K Number
    K232852
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5175
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cross Vascular, Inc.
    Date Received
    September 14, 2023
    Decision Date
    October 12, 2023
    Product Code
    DXF
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    DXF Catheter, Septostomy

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    Other Clearances by Cross Vascular, Inc.

    K Number Device Name
    K232809 Cross Vascular RF Generator and Footswitch (optional accessory)