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

    TEFLON CANNULA

    K Number: K822776 · Decision Nov 3, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    205
    Same Product Code
    503
    Applicant Total
    76
    Review Days
    50

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    Basic Information

    Device Name
    TEFLON CANNULA
    K Number
    K822776
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Cardiac Pacemakers, Inc.
    Date Received
    September 14, 1982
    Decision Date
    November 3, 1982
    Product Code
    FOZ
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

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    Other Clearances by Cardiac Pacemakers, Inc.

    K Number Device Name
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    K920601 ASTRA T2, ASTRA T4, ASTRA T6
    K912379 PDT CARRYALL TRANSMITTER, VARIOUS MODELS
    K905674 LEAD STYLET
    K900498 MODIFIED BETATRON IV INSULIN INFUSION SYSTEM
    K894738 MODEL 6888 LEAD TUNNELER
    K890785 ASTRA T2, T3, T4, T6 PULSE GENERATORS NEW PACKAGE
    K875147 TORQUE HEX WRENCH
    Search all 76 clearances from Cardiac Pacemakers, Inc. →