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

    BRESAGEN CATHETER, MODEL CS-3000

    K Number: K021481 · Decision Aug 6, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    9
    Applicant Total
    1
    Review Days
    90

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    Basic Information

    Device Name
    BRESAGEN CATHETER, MODEL CS-3000
    K Number
    K021481
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4100
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Bresagen, Inc.
    Date Received
    May 8, 2002
    Decision Date
    August 6, 2002
    Product Code
    HCA
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HCA Catheter, Ventricular

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