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

    MEMCATH UROLOGY INTRODUCER SHEATH, MODEL 201

    K Number: K000767 · Decision Jun 5, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    63
    Applicant Total
    2
    Review Days
    88

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    Basic Information

    Device Name
    MEMCATH UROLOGY INTRODUCER SHEATH, MODEL 201
    K Number
    K000767
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Memcath Technologies, LLC
    Date Received
    March 9, 2000
    Decision Date
    June 5, 2000
    Product Code
    KNY
    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
    KNY Accessories, Catheter, G-U

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    Other Clearances by Memcath Technologies, LLC

    K Number Device Name
    K993226 MEMCATH UROLOGY CATHETER, MODEL 101 -000 - 006