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510(k) Data Aggregation

    K Number
    K133853
    Device Name
    VIEWFLEX XTRA ICE CATHETER
    Manufacturer
    IRVINE BIOMEDICAL, INC. A ST.JUDE MEDICAL COMPANY
    Date Cleared
    2014-05-19

    (151 days)

    Product Code
    OBJ
    Regulation Number
    870.1200
    Why did this record match?
    Applicant Name (Manufacturer) :

    IRVINE BIOMEDICAL, INC. A ST.JUDE MEDICAL COMPANY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ViewFlex Xtra ICE Catheter is indicated for use in adult and adolescent pediatric patients to visualize cardiac structures, blood flow and other devices within the heart.
    Device Description
    The ViewFlex Xtra ICE Catheter is inserted into the heart via intravascular access. The ViewFlex Xtra is a sterile, single use, temporary, intracardiac ultrasound catheter indicated for use in adult and adolescent pediatric patients. The ViewFlex catheter shaft is a 9 French catheter constructed with radiopaque tubing with a useable length of 90 cm. The shaft is compatible with a 10 French or larger introducer for insertion into the femoral or jugular veins. The catheter tip is a 64-element linear phased array transducer housed in silicone. The distal portion of the shaft is deflectable in four directions allowing for left-to-right and anterior-to-posterior deflection. The handle of the device has two deflection mechanisms that correspond with the movement of the distal shaft in the four planes of movement. The ViewFlex Xtra is compatible with ViewMate II, ViewMate Z and Philips CX50 ultrasound consoles.
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