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

    CROSSPOINT TRANSACCESS CATHETER, MODEL TA-XP-001

    K Number: K031920 · Decision Jul 23, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    388
    Registration Numbers
    389
    Same Product Code
    407
    Applicant Total
    2
    Review Days
    30

    Basic Information

    Device Name
    CROSSPOINT TRANSACCESS CATHETER, MODEL TA-XP-001
    K Number
    K031920
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.1570
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    TRANS VASCULAR INCORPORATED
    Date Received
    June 23, 2003
    Decision Date
    July 23, 2003
    Product Code
    ITX
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    ITX Transducer, Ultrasonic, Diagnostic

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