BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    PERITONEAL DIALYSIS CATHETERS AND ADAPTERS

    K Number: K993149 · Decision Apr 28, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    47
    Applicant Total
    4
    Review Days
    220

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    Basic Information

    Device Name
    PERITONEAL DIALYSIS CATHETERS AND ADAPTERS
    K Number
    K993149
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5630
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medionics International, Inc.
    Date Received
    September 21, 1999
    Decision Date
    April 28, 2000
    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 Medionics International, Inc.

    K Number Device Name
    K130441 FALLER STYLET
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