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

    BALLOON DILATION CATHETER

    K Number: K896448 · Decision Mar 7, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    55
    Applicant Total
    43
    Review Days
    118

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    Basic Information

    Device Name
    BALLOON DILATION CATHETER
    K Number
    K896448
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5470
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Cook Ob/Gyn
    Date Received
    November 9, 1989
    Decision Date
    March 7, 1990
    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 Cook Ob/Gyn

    K Number Device Name
    K062438 BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500
    K030441 SYDNEY IVF BLASTOCYST CRYOPRESERVATION KIT AND SYDNEY IVF BLASTOCYST THAW KIT
    K023850 SYDNEY IVF EMBRYO BIOPSY MEDIUM
    K013597 TAMPONADE UTERINE BALLOON CATHETER SET
    K002385 COOK IVF FOLLICLE FLUSHING BUFFER, COOK IVF OOCYTE WASH BUFFER, COOK IVF FERTILIZATION MEDIUM, COOK IVF CLEAVAGE MEDIUM,
    K002383 COOK IVF SPERM BUFFER, COOK IVF SPERM MEDIUM, AND COOK IVF SPERM GRADIENT KIT
    K983595 TRANSMYOMETRIAL EMBRYO TRANSFER SET
    K983596 INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES, ASSISTED HATCHING
    K983642 COOK MINI-INCUBATOR
    K983593 OVUM PICK-UP ASPIRATION NEEDLES
    Search all 43 clearances from Cook Ob/Gyn →