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

    PERIMETER THORACIC CATHETER

    K Number: K844922 · Decision Mar 18, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    243
    Registration Numbers
    243
    Same Product Code
    76
    Applicant Total
    5
    Review Days
    89

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    Basic Information

    Device Name
    PERIMETER THORACIC CATHETER
    K Number
    K844922
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4200
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Perimeter Medical, Inc.
    Date Received
    December 19, 1984
    Decision Date
    March 18, 1985
    Product Code
    GBX
    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
    GBX Catheter, Irrigation

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    Other Clearances by Perimeter Medical, Inc.

    K Number Device Name
    K844924 PERIMETER YANKAUER SUCTION TIPS & SETS
    K844921 PERIMETER CLOSED WOUND RESEVOIR
    K844925 PERIMETER MEDIASTINAL DRAIN
    K844923 PERIMETER SUMP DRAIN