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

    BLAZER DX-20 DIAGNOSTIC CATHETER

    K Number: K081576 · Decision Feb 3, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    86
    Registration Numbers
    86
    Same Product Code
    182
    Applicant Total
    430
    Review Days
    243

    Basic Information

    Device Name
    BLAZER DX-20 DIAGNOSTIC CATHETER
    K Number
    K081576
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1220
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    BOSTON SCIENTIFIC CORP.
    Date Received
    June 5, 2008
    Decision Date
    February 3, 2009
    Product Code
    DRF
    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
    DRF Catheter, Electrode Recording, Or Probe, Electrode Recording

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