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510(k) Data Aggregation

    K Number
    K970049
    Device Name
    BSC, SONICATH ULTRA IMAGING CATHETER 3.2F/20MHZ(37410/456221 & BSC, SONICATH ULTRA IMAGING CATHETER 2.9F/20MHZ/37411/
    Manufacturer
    CARDIOVASCULAR IMAGING SYSTEMS, INC.
    Date Cleared
    1997-06-20

    (165 days)

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

    CARDIOVASCULAR IMAGING SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sonicath Ultra Imaging Catheter is intended for the ultrasound examination of peripheral and coronary intravascular pathology. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.
    Device Description
    The BSC Sonicath Ultra Imaging Catheter is a sterile, single-use disposable device used for the ultrasound examination of intravascular pathology in both the coronary and peripheral vasculatures. The Sonicath Ultra 2.9 F and 3.2 F Imaging Catheters and predicate devices consist of two main components: (1) the catheter body and (2) the imaging core. The imaging core of both the Sonicath Ultra and the predicate device imaging catheters is comprised of a hitorque, flexible, rotating drive cable with an outward looking ultrasonic transducer at the distal tip.
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