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

    RMI FEMORAL VENOUS DRAINAGE CANNULA

    K Number: K863740 · Decision Feb 19, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    104
    Registration Numbers
    104
    Same Product Code
    400
    Applicant Total
    35
    Review Days
    149

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    Basic Information

    Device Name
    RMI FEMORAL VENOUS DRAINAGE CANNULA
    K Number
    K863740
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4210
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Research Medical, Inc.
    Date Received
    September 23, 1986
    Decision Date
    February 19, 1987
    Product Code
    DWF
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

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    Other Clearances by Research Medical, Inc.

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    K961927 RMI HEMOCONCENTRACTOR TUBING SET
    K960098 RMI INTERNAL MAMMARY ARTERY CANNULA
    K951344 RMI HEMOCONCENTRATOR
    K922083 RMI SURGICCAL SITE VISUALIZATION WAND
    K920936 RMI EXTERNAL CORONARY ARTERY OCCLUDER
    K915869 RMI NORMOCLUDER CORONARY ARTERY OCCLUDER
    K920676 RMI SOFCLAMP
    K910221 RMI VASCULAR TOURNIQUET KIT
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