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510(k) Data Aggregation

    K Number
    K041504
    Device Name
    HEMAMYST SURGICAL APPLICATOR SYSTEM, MODEL H-AS01
    Manufacturer
    Date Cleared
    2004-08-06

    (60 days)

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

    HAEMACURE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The HemaMyst Surgical Applicator System is indicated for the simultaneous application of the two separate components of HEMASEEL APR Fibrin Sealant or Tisseel VH Fibrin Sealant to the treatment site.
    Device Description
    The HemaMyst Surgical Applicator System is a sterile, single-use device consisting of a Head that attaches by Luer connectors to currently available dual syringe spray noals and is coupled to an air regulator base unit by means of a sterile filtered air applicators, and is obablicator System allows simultaneous delivery, by spraying, of the two components of fibrin sealant to the treatment site.
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    K Number
    K994023
    Device Name
    HAEMACURE HEMAMYST SURGICAL APPLICATOR SYSTEM H-AS01
    Manufacturer
    Date Cleared
    2000-04-25

    (151 days)

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

    HAEMACURE CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Haemacure HemaMyst Surgical Applicator System is indicated for the application of two non-homogeneous fluids or solutions to the treatment site.
    Device Description
    The Haemacure HemaMyst Surgical Applicator System consists of an air regulator that can be coupled with compressed gasses present in the operating suite, a foot pedal to control air flow; and a spray head that can be coupled to currently available dual syringe applicators with a filtered air line to connect the base unit to the applicator spray head. The base unit with the regulator and foot pedal is provided non-sterile and sold as a reusable device. The spray head and filtered gas tubing is ethylene oxide (EtO) sterilized and sold as a sterile, single-use device.
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