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

    KENDALL INFANT ECMO VENOVENOUS CATHETER-DUAL LUMEN

    K Number: K895352 · Decision Nov 29, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    104
    Registration Numbers
    104
    Same Product Code
    400
    Applicant Total
    66
    Review Days
    89

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    Basic Information

    Device Name
    KENDALL INFANT ECMO VENOVENOUS CATHETER-DUAL LUMEN
    K Number
    K895352
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4210
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Kendall Healthcare Products Co. Div.Of Tyco Health
    Date Received
    September 1, 1989
    Decision Date
    November 29, 1989
    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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    K973619 KENDALL CURITY NON-ADHERING DRESSING
    K973509 KENDALL CURASORB ZN + MG ALGINATE WOUND DRESSING
    K973546 KENDALL FAST-CATH PRE LUBRICATED URETHRAL CATHETER
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    K963446 KENDALL DUAL LUMEN CATHETER
    K964899 KENDALL CURITY URETERAL CATHETER
    K964519 CURITY THORACENTESIS TRAY
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