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510(k) Data Aggregation

    K Number
    K984062
    Device Name
    SEAL-AWAY HEMOSTASIS ADAPTER, MODEL 406229
    Manufacturer
    DIAG CORP.
    Date Cleared
    1999-03-24

    (128 days)

    Product Code
    DYB
    Regulation Number
    870.1340
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIAG CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Seal-Away™ Hemostasis Adapters are designed for the introduction of angiographic catheters, closed end catheters, balloon catheters and electrodes into a vessel where minimizing the blood loss is essential.
    Device Description
    The Daig Seal-Away™ Hemostasis Adapter is an Introducer Accessory designed to provide easy access to the vascular system while providing convenient temporary closure of a standard indwelling introducer access site during introduction of pacing leads, angiographic catheters, closed end catheters, balloon catheters and electrodes into a vessel.
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