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

    NON-STERILE PERITONEAL ACCESS CATHET-

    K Number: K830257 · Decision Feb 24, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    82
    Applicant Total
    6
    Review Days
    30

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    Basic Information

    Device Name
    NON-STERILE PERITONEAL ACCESS CATHET-
    K Number
    K830257
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5630
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Evermed, Inc.
    Date Received
    January 25, 1983
    Decision Date
    February 24, 1983
    Product Code
    FKX
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FKX System, Peritoneal, Automatic Delivery

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    Other Clearances by Evermed, Inc.

    K Number Device Name
    K840846 STERILE HICHMAN/BROVIAC INJECTION CAP
    K840529 STEIGER TUNNELING INSTRUMENT 285
    K830406 NON-STERILE CATHETER REPAIR KITS
    K830256 NON-STERILE BROVIAC PARENTERAL ALIMI-
    K830233 NON-STERILE,SINGLE/SOUBLE LUMEN-CATH