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

    FLEX-NECK EXXTENDED PERITONEAL DIALYSIS CATHETER AND ACCESSORIES, MODEL CF-5560

    K Number: K071167 · Decision Aug 31, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    47
    Applicant Total
    6
    Review Days
    127

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    Basic Information

    Device Name
    FLEX-NECK EXXTENDED PERITONEAL DIALYSIS CATHETER AND ACCESSORIES, MODEL CF-5560
    K Number
    K071167
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5630
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    Medigroup, Inc.
    Date Received
    April 26, 2007
    Decision Date
    August 31, 2007
    Product Code
    FJS
    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
    FJS Catheter, Peritoneal, Long-Term Indwelling

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    Other Clearances by Medigroup, Inc.

    K Number Device Name
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