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

    FIXATION STYLETS, MODELS 335-287 AND 335-288

    K Number: K000366 · Decision Apr 14, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    27
    Applicant Total
    1
    Review Days
    70

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    Basic Information

    Device Name
    FIXATION STYLETS, MODELS 335-287 AND 335-288
    K Number
    K000366
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1380
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Accufix Research Institute
    Date Received
    February 4, 2000
    Decision Date
    April 14, 2000
    Product Code
    DRB
    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
    DRB Stylet, Catheter

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