BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    EMBOSPHERE MICROSPHERES AND EMBOGOLD MICROSPHERES FOR USE IN UTERINE FIBROID EMBOLIZATION

    K Number: K021397 · Decision Nov 22, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    7
    Applicant Total
    6
    Review Days
    204

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    EMBOSPHERE MICROSPHERES AND EMBOGOLD MICROSPHERES FOR USE IN UTERINE FIBROID EMBOLIZATION
    K Number
    K021397
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biosphere Medical, Inc.
    Date Received
    May 2, 2002
    Decision Date
    November 22, 2002
    Product Code
    NAJ
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NAJ Agents, Embolic, For Treatment Of Uterine Fibroids

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (NAJ), ordered by most recent decision date.

    Bearing nsPVA Express™

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BEARING NSPVA EMBOLIZATION PARTICLES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CONTOUR EMBOLIZATION PARTICLES, MODELS M0017600121, M0017600221, M0017600321

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    COOK INCORPORATED POLYVINYL ALCOHOL FOAM EMBOLIZATION PARTICLES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all

    Other Clearances by Biosphere Medical, Inc.

    K Number Device Name
    K113822 QUADRASPHERE 30 TO 60
    K052742 HEPASPHERE MICROSPHERES
    K062126 EMBOCATH PLUS INFUSION MICROCATHETER, MODEL ECP-100 AND ECP-135
    K061171 SEQUITOR STEERABLE GUIDEWIRE, MODELS SQR18XX AND SQR14XX
    K010026 EMBOGOLD MICROSPHERE