LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K050495
    Device Name
    EASYSPRAY AND SPRAY SET FOR TISSEEL (FIBER SEALANT)
    Manufacturer
    BAXTER HEALTHCARE CORP., BIOSCIENCE
    Date Cleared
    2005-05-02

    (63 days)

    Product Code
    FMF
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    BAXTER HEALTHCARE CORP., BIOSCIENCE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The EasySpray and Spray Set are intended for use in the simultaneous application of TISSEEL Two-Component Fibrin Sealant using the DUPLOJECT System
    Device Description
    The EasySpray and Spray Set system represents minor design modifications to the TISSOMAT and Spray Set, 510(k) K981089. The purpose of the design modifications is to accommodate a change in the location of the gas on/off function of the system. The original TISSOMAT and Spray Set design includes a foot pedal to turn the gas flow on and off. The EasySpray and Spray Set system moves the control from a foot pedal, to a clip that attaches to the back end of the DUPLOJECT.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1