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

    OPTI-FLOW DIGITAL SUBTRACTION ANGIOGRAPHY CAT-KIT

    K Number: K844854 · Decision May 21, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    210
    Registration Numbers
    211
    Same Product Code
    499
    Applicant Total
    19
    Review Days
    159

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    Basic Information

    Device Name
    OPTI-FLOW DIGITAL SUBTRACTION ANGIOGRAPHY CAT-KIT
    K Number
    K844854
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Vas-Cath of Canada , Ltd.
    Date Received
    December 13, 1984
    Decision Date
    May 21, 1985
    Product Code
    DQO
    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
    DQO Catheter, Intravascular, Diagnostic

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    Other Clearances by Vas-Cath of Canada , Ltd.

    K Number Device Name
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    K871487 VAS-CATH PERMANENT SINGLE LUMEN HEMODIALYSIS CATH
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    K853283 VACCESS TM 4006
    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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