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510(k) Data Aggregation

    K Number
    K031920
    Device Name
    CROSSPOINT TRANSACCESS CATHETER, MODEL TA-XP-001
    Manufacturer
    TRANS VASCULAR INCORPORATED
    Date Cleared
    2003-07-23

    (30 days)

    Product Code
    ITX, DQY
    Regulation Number
    892.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRANS VASCULAR INCORPORATED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CrossPoint TransAccess Catheter is intended to facilitate the placement and positioning of catheters within the peripheral vasculature. The CrossPoint TransAccess Catheter also provides an intra-luminal, cross-sectional ultrasound image of the area of interest. The CrossPoint TransAccess Catheter is not indicated for use in the coronary or cerebral vasculature.
    Device Description
    The subject device (CrossPoint TransAccess Catheter) is substantially equivalent in intended use and/or method of operation to the original CrossPoint TransAccess Catheter (K013363).
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    K Number
    K013363
    Device Name
    CROSSPOINT TRANSACCESS CATHETER
    Manufacturer
    TRANS VASCULAR INCORPORATED
    Date Cleared
    2002-04-02

    (174 days)

    Product Code
    ITX
    Regulation Number
    892.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRANS VASCULAR INCORPORATED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CrossPoint TransAccess Catheter is intended to facilitate the placement and positioning of catheters within the peripheral vasculature. The CrossPoint TransAccess Catheter also provides an intraluminal, cross-sectional ultrasound image of the area of interest. The CrossPoint TransAccess Catheter is not indicated for use in the coronary or cerebral vasculature.
    Device Description
    The CrossPoint TransAccess Catheter is intended to facilitate the placement and positioning of catheters within the peripheral vasculature. The CrossPoint TransAccess Catheter also provides an intraluminal, cross-sectional ultrasound image of the area of interest.
    Ask a Question

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