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

    PATHWAY ACCESS SHEATH CATHETER

    K Number: K030662 · Decision Sep 3, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    55
    Applicant Total
    3
    Review Days
    184

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    Basic Information

    Device Name
    PATHWAY ACCESS SHEATH CATHETER
    K Number
    K030662
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5470
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Vertelink Corporation
    Date Received
    March 3, 2003
    Decision Date
    September 3, 2003
    Product Code
    EZN
    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
    EZN Dilator, Catheter, Ureteral

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    Other Clearances by Vertelink Corporation

    K Number Device Name
    K032102 VERTELINK KOBRA SPINAL FIXATION SYSTEM
    K030734 PATHWAY ACCESS SHEATH CATHETER