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

    BIOMERIX VASCULAR OCCLUSION DEVICE AND LOADER

    K Number: K043371 · Decision Feb 3, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    103
    Registration Numbers
    103
    Same Product Code
    128
    Applicant Total
    6
    Review Days
    57

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    Basic Information

    Device Name
    BIOMERIX VASCULAR OCCLUSION DEVICE AND LOADER
    K Number
    K043371
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biomerix Corporation
    Date Received
    December 8, 2004
    Decision Date
    February 3, 2005
    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

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    Other Clearances by Biomerix Corporation

    K Number Device Name
    K112499 BIOMERIX COMPOSITE SURGICAL MESH
    K112567 BIOMERIX ASSURE
    K093123 BIOMERIX VENTRAL HERNIA REPAIR MESH, MODEL SM3-TAB
    K082941 BIOMERIX COMPOSITE SURGICAL MESH, MODEL SMNR-0510 AND SMNR-1215
    K070961 BIOMERIX SURGICAL MESH, MODEL: RCR-01