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510(k) Data Aggregation

    K Number
    K234123
    Device Name
    Easi-Vue® embolic microspheres System
    Manufacturer
    Date Cleared
    2024-02-13

    (47 days)

    Product Code
    Regulation Number
    870.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    ABK Biomedical Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Easi-Vue® embolic microspheres System is intended for embolization of arteriovenous malformations and hypervasular tumors.
    Device Description
    Easi-Vue embolic microspheres are biocompatible, radiopaque, non-compressible, non-resorbable glass microspheres. The Easi-Vue embolic microspheres are included with the Easi-Vue embolic microspheres System which is comprised of Easi-Vue embolic microspheres Delivery Device and the Easi-Vue embolic microspheres Refill Syringe. The Delivery Device provides for controlled and targeted delivery of imageable radiopaque microspheres contained in the Refill Syringe. The Easi-Vue® embolic microspheres System is offered in three sizes: 50um, 100μm, and 150μm to occlude various size arteries for the purpose of blocking blood flow to a target tissue (as summarized in Table 1). The Easi-Vue embolic microsphere System is sterile, single use, and available only for prescription use. The device is compatible with a catheter with minimum inner diameter of 0.021" and a length between 110-150 cm (as appropriate for the diameter of the intended treatment vessel).
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    K Number
    K220567
    Device Name
    Easi-Vue embolic microspheres System
    Manufacturer
    Date Cleared
    2022-09-07

    (191 days)

    Product Code
    Regulation Number
    870.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    ABK Biomedical Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Easi-Vue™ embolic microspheres System is intended for embolization of arteriovenous malformations and hypervasular tumors.
    Device Description
    Easi-Vue embolic microspheres are biocompatible, radiopaque, non-compressible, non-resorbable glass microspheres. The Easi-Vue embolic microspheres are included with the Easi-Vue embolic microspheres System which is comprised of Easi-Vue embolic microspheres Administration Kit and the Easi-Vue embolic microspheres Refill Syringe. The device utilizes the Administration Kit for controlled and targeted delivery of imageable radiopaque microspheres. The Easi-Vue™ embolic microspheres System is offered in three sizes: 50 um, and 150 um to occlude various size arteries for the purpose of blocking blood flow to a target tissue (as summarized in Table 1). The Easi-Vue™ embolic microsphere System is sterile, single use, and available only for prescription use. The device is compatible with a catheter with minimum inner diameter of 0.021'' and a length between 110-150 cm (as appropriate for the diameter of the intended treatment vessel).
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