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510(k) Data Aggregation

    K Number
    K141209
    Device Name
    EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES, ONCOZENE MICROSPHERES
    Manufacturer
    CELONOVA BIOSCIENCES, INC.
    Date Cleared
    2014-08-07

    (90 days)

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

    CELONOVA BIOSCIENCES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Embozene® Microspheres are indicated for the embolization of arteriovenous malformations and hypervascular tumors including uterine fibroids and hepatoma. ONCOZENE™ Microspheres are indicated for the embolization of arteriovenous malformations and hypervascular tumors including hepatoma.
    Device Description
    Embozene® Microspheres and ONCOZENE™ Microspheres are tightly calibrated, compressible microspheres intended to occlude vasculature for the purpose of blocking blood flow to a target tissue such as a hypervascular tumor (HVT) or arteriovenous malformation (AVM). The microspheres are manufactured from sodium polymethacrylate and coated with proprietary Polyzene®F. The microspheres are compressible to enable smooth delivery through the indicated delivery catheter. Embozene® Microspheres are available opaque or color coded by size to allow easy identification of the different sizes; ONCOZENE™ Microspheres are available in opaque only. Embozene® / ONCOZENE™ Microspheres are supplied sterile and packaged in 20ml polycycloolefin syringes with a standard 7ml fill volume across the range. Embozene® Microspheres syringes or vials are available in 1 ml or 2 ml microsphere volume; ONCOZENE™ Microspheres are available in 2 ml or 3 ml microsphere volume.
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    K Number
    K132675
    Device Name
    EMBOZENE MICROSPHERES
    Manufacturer
    CELONOVA BIOSCIENCES, INC.
    Date Cleared
    2013-10-03

    (36 days)

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

    CELONOVA BIOSCIENCES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Embozene® Microspheres are intended for embolization of hypervascular tumors and arteriovenous malformations.
    Device Description
    Embozene® Microspheres are tightly calibrated, compressible microspheres intended to occlude vasculature for the purpose of blocking blood flow to a target tissue such as hypervascular tumor (HVT) or arteriovenous malformation (AVM). Embozene® Microspheres are manufactured from sodium polymethacrylate and coated with proprietary Polyzene®-F. The microspheres are compressible to enable smooth delivery through the indicated delivery catheter. Embozene® Microspheres are color coded by size to allow easy identification of different sizes. Embozene® Microspheres are supplied sterile and packaged in 20ml polycycloolefin syringes with a standard 7ml fill volume across the range. Embozene® Microspheres syringes and vials are available with 1 ml or 2 ml microsphere volume per syringe or vial.
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