BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    Valved Safety Centesis Catheter

    K Number: K150800 · Decision Nov 12, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    78
    Registration Numbers
    78
    Same Product Code
    7
    Applicant Total
    149
    Review Days
    231

    Basic Information

    Device Name
    Valved Safety Centesis Catheter
    K Number
    K150800
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4200
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    B.Braun Medical, Inc.
    Date Received
    March 26, 2015
    Decision Date
    November 12, 2015
    Product Code
    GCB
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GCB Needle, Catheter

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