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

    PERITONEAL DIALYSIS CATHETER CONNECTOR

    K Number: K974570 · Decision Feb 27, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    15
    Applicant Total
    6
    Review Days
    81

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    Basic Information

    Device Name
    PERITONEAL DIALYSIS CATHETER CONNECTOR
    K Number
    K974570
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5630
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medigroup, Inc.
    Date Received
    December 8, 1997
    Decision Date
    February 27, 1998
    Product Code
    FKO
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FKO Catheter, Peritoneal Dialysis, Single Use

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    Other Clearances by Medigroup, Inc.

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    K070730 FLEX-NECK ARC CATHETER
    K060897 EMBEDDING TOOL, MODEL TE-1000
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