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510(k) Data Aggregation

    K Number
    K062868
    Device Name
    THE CROSSER CATHETER, MODEL CR1100 AND SYSTEM ELECTRONICS, MODEL FG1002-02
    Manufacturer
    FLOWCARDIA INC
    Date Cleared
    2007-01-19

    (116 days)

    Product Code
    DQY
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    FLOWCARDIA INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CROSSER System is indicated in coronary arteries to facilitate the intra-luminal placement of conventional guidewires beyond chronic total occlusions.
    Device Description
    The CROSSER System consists of a re-usable electronic Generator, Foot Switch, high frequency Transducer, and single-use CROSSER 14 Catheter. The CROSSER 14 Catheter is connected to the electronic Generator through the Transducer. The Foot Switch is used to activate the system. The Generator and Transducer convert AC power into high frequency mechanical vibrations which are propagated through a Nitinol core wire to the stainless steel tip of the CROSSER 14 Catheter. The main body of the catheter is constructed from Pebax and a hydrophilic coating which covers the distal 90cm of the catheter.
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