BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇷 France

    EmboCube Embolization Gelatin

    K Number: K183120 · Decision Aug 6, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    103
    Registration Numbers
    103
    Same Product Code
    128
    Applicant Total
    10
    Review Days
    270

    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
    EmboCube Embolization Gelatin
    K Number
    K183120
    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, S.A.
    Date Received
    November 9, 2018
    Decision Date
    August 6, 2019
    Product Code
    KRD
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KRD Device, Vascular, For Promoting Embolization

    Similar 510(k) Clearances

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

    HARBOR Occlusion Device

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LOBO Vascular Occlusion System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Concerto Versa™ Detachable Coil

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Tembo Embolic System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OBSIDIO™ Conformable Embolic (M0013972101010)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Polyvinyl Alcohol Embolic Microspheres

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

    Other Clearances by Biosphere Medical, S.A.

    K Number Device Name
    K250971 Embosphere Microspheres
    K192480 Torpedo Gelatin Foam
    K183578 Torpedo Gelatin Foam
    K181021 EmboCube Embolization Gelatin
    K181300 Embosphere Microspheres
    K172372 QuadraSphere Microspheres
    DEN160040 Embosphere Microspheres
    K153102 QuadraSphere Microspheres
    K151187 QuadraSphere Microspheres