LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K250209
    Device Name
    Polyvinyl Alcohol Embolic Microspheres
    Manufacturer
    Canyon Medical Inc.
    Date Cleared
    2025-09-23

    (242 days)

    Product Code
    KRD
    Regulation Number
    870.3300
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K173871
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Polyvinyl Alcohol Embolic Microspheres are intended to be used for the embolization of arteriovenous malformations (AVMs) and hypervascular tumors, including uterine fibroids.

    Device Description

    The subject device polyvinyl alcohol 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. The embolic microspheres consist of a macromer derived from polyvinyl alcohol (PVA) and are hydrophilic, non-resorbable. The preservation solution is 0.9% sodium chloride solution.

    The polyvinyl alcohol embolic microspheres available in dyed (blue) and clear (undyed with natural color). The subject device available in particle sizes from 75-1200μm and supplied sterile in sterile sealed glass vials which contain 1 mL, 2 mL, or 3 mL of microspheres suspended in 7mL, 7mL, or 6 mL of 0.9% sodium chloride solution, respectively.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1