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

    ATRIUMS PDR THORACIC CATHETER

    K Number: K912645 · Decision Sep 13, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    26
    Applicant Total
    63
    Review Days
    88

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    Basic Information

    Device Name
    ATRIUMS PDR THORACIC CATHETER
    K Number
    K912645
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4200
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Atrium Medical Corp.
    Date Received
    June 17, 1991
    Decision Date
    September 13, 1991
    Product Code
    GBS
    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
    GBS Catheter, Ventricular, General & Plastic Surgery

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