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510(k) Data Aggregation

    K Number
    K210562
    Device Name
    HRSpheres Narrow-Size Embolic Microspheres
    Date Cleared
    2021-10-01

    (218 days)

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

    Suzhou Hengrui Hongyuan Medical Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    HRSpheres Narrow-Size Embolic Microspheres are intended to be used for the embolization of arteriovenous malformations (AVMs) and hypervascular tumors, including uterine fibroids.
    Device Description
    HRSpheres Narrow-Size Embolic Microspheres are compressible hydrogel microspheres with a regular shape, smooth surface, and calibrated size, which are formed as a result of chemical modification on polyvinyl alcohol (PVA) materials. HRSpheres Narrow-Size Embolic Microspheres consist of a macromer derived from PVA, and are hydrophilic, non-resorbable, and are available in a variety of diameters ranging from 70 - 1,200 um. The preservation solution is 0.9% sodium chloride solution. The water content of a fully polymerized microsphere is 91% ~ 94%. Microspheres are compressible to enable smooth delivery through the indicated delivery catheter. The HRSpheres are available in dyed (blue) and clear (undyed with natural color). Blue-dyed microspheres aid in the visualization of the microspheres in the delivery syringe. HRSpheres Narrow-Size Embolic Microspheres are packaged in sterile sealed glass vials for single use only and available with 1 mL, 2 mL, or 3 mL microspheres volumes per vial. HRSpheres Narrow-Size Embolic Microspheres can be delivered to a targeted area through typical microcatheters in the 1.7 – 4 Fr range. By blocking the blood supply to the target area, the tumor or malformation is starved of nutrients and shrinks in size. At the time of use. HRSpheres Narrow-Size Embolic Microspheres are mixed with a nonionic contrast agent to form a suspension solution and aid in visualization during a procedure.
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