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

    AVD INTIMAX CHOLANGIOGRAPHY CATHETER

    K Number: K910493 · Decision Mar 28, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    143
    Registration Numbers
    143
    Same Product Code
    473
    Applicant Total
    21
    Review Days
    51

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    Basic Information

    Device Name
    AVD INTIMAX CHOLANGIOGRAPHY CATHETER
    K Number
    K910493
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5010
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Applied Vascular Devices, Inc.
    Date Received
    February 5, 1991
    Decision Date
    March 28, 1991
    Product Code
    FGE
    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
    FGE Stents, Drains And Dilators For The Biliary Ducts

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    Other Clearances by Applied Vascular Devices, Inc.

    K Number Device Name
    K911730 SURGICAL OBTURATOR WITH SEAL
    K911589 DISPOSABLE SURGICAL TROCAR WITH SEAL
    K910339 AVD INTIMAX OCCLUSION CATHETER
    K910372 INTIMAX THROMBECTOMY CATHETER
    K911181 INTIMAX(TM) IRRIGATION CATHETER
    K903848 DIAGNOSTIC INTRASCULAR CATHETER
    K905738 OPERATIVE CHOLANGIOGRAPHIC CATHETER
    K910079 DISPOSABLE INTRODUCER SHEATH
    K902256 IRRIGATION CATHETER 4, 6 AND 10 FRENCH
    K904379 SURGICAL TROCAR AND CANNULA
    Search all 21 clearances from Applied Vascular Devices, Inc. →