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

    KENDALL DUAL LUMEN CATHETER

    K Number: K963446 · Decision Mar 18, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    37
    Applicant Total
    66
    Review Days
    196

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    Basic Information

    Device Name
    KENDALL DUAL LUMEN CATHETER
    K Number
    K963446
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5540
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kendall Healthcare Products Co. Div.Of Tyco Health
    Date Received
    September 3, 1996
    Decision Date
    March 18, 1997
    Product Code
    MPB
    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
    MPB Catheter, Hemodialysis, Non-Implanted

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    Other Clearances by Kendall Healthcare Products Co. Div.Of Tyco Health

    K Number Device Name
    K973763 KENDALL CURITY IODOFORM PACKING STRIP
    K973511 KENDALL CURITY PETROLATUM GAUZE
    K973507 KENDALL XEROFORM PETROLATUM DRESSING (6311,6312,6313,6314,6315,6316,6317)
    K973619 KENDALL CURITY NON-ADHERING DRESSING
    K973509 KENDALL CURASORB ZN + MG ALGINATE WOUND DRESSING
    K973546 KENDALL FAST-CATH PRE LUBRICATED URETHRAL CATHETER
    K970266 KENDALL HYDROPHILIC POWDER WOUND DRESSING
    K964899 KENDALL CURITY URETERAL CATHETER
    K964519 CURITY THORACENTESIS TRAY
    K961977 KENDALL SHER-I-BRONCH ENDOBROCHIAL TUBE
    Search all 66 clearances from Kendall Healthcare Products Co. Div.Of Tyco Health →