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510(k) Data Aggregation

    K Number
    K042297
    Device Name
    ULTRA IVALON AND ULTRA DRIVALON PVA EMBOLIZATION PARTICLES
    Manufacturer
    ACTA VASCULAR SYSTEMS, INC.
    Date Cleared
    2005-06-01

    (281 days)

    Product Code
    HCGKRD
    Regulation Number
    882.5950
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACTA VASCULAR SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Ultra IVALON and Ultra DRIVALON PVA Embolization Particles are intended for the embolization of hypervascular tumors and arteriovenous malformations (AVMs).
    Device Description
    Ultra IVALON and Ultra DRIVALON PVA Embolization Particles are artificial embolization devices used for permanent embolization of hypervascular lesions and arteriovenous malformations (AVMs) via superselective catheter delivery. The embolization particles are supplied in various size ranges to enable appropriate size selection for the lesion to be treated. Ultra IVALON and Ultra DRIVALON PVA Embolization Particles are designed to be delivered under fluoroscopic guidance through compatible infusion/delivery catheters. Ultra IVALON PVA Embolization Particles are suspended in 0.9% saline (NaCI) solution. Uttra DRIVALON PVA Embolization Particles are packaged in a dry form. Each unit contains 0.1g of particles.
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