BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    VAS-CATH PERMANENT SINGLE LUMEN HEMODIALYSIS CATH

    K Number: K871487 · Decision Jun 12, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    64
    Applicant Total
    19
    Review Days
    58

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    Basic Information

    Device Name
    VAS-CATH PERMANENT SINGLE LUMEN HEMODIALYSIS CATH
    K Number
    K871487
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5540
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Vas-Cath of Canada , Ltd.
    Date Received
    April 15, 1987
    Decision Date
    June 12, 1987
    Product Code
    LFJ
    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
    LFJ Catheter, Subclavian

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    K863982 VAS-CATH PERICARDIOCENTESIS CATHETER, SET & TRAY
    K853283 VACCESS TM 4006
    K844854 OPTI-FLOW DIGITAL SUBTRACTION ANGIOGRAPHY CAT-KIT
    K844800 OPTI-FLOW & OPTI-TORQUE ANGIOGRAPHIC CATHETERS
    K850009 EVANS, VAS-CATH EPIDURAL NEEDLE & CATHETER
    K844336 VAS-CATH PARALLEL DUAL LUMAN JUGULAR CANNUAL CATH
    K844433 VACCESS 2000 SINGLE LUMEN SUBCLAVIAN CANNULA
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