BEUDAMED
    FDA 510(k) FDA class 3 Substantially Equivalent 🇺🇸 United States

    LASERDISH POLY UNIPOLAR VENTRI LEAD W/TRAIL TINES

    K Number: K904741 · Decision Jan 8, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    486
    Applicant Total
    20
    Review Days
    82

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    Basic Information

    Device Name
    LASERDISH POLY UNIPOLAR VENTRI LEAD W/TRAIL TINES
    K Number
    K904741
    Device Class
    FDA class 3
    Clearance Type
    Traditional
    Regulation Number
    870.3680
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Telectronics Pacing Systems, Inc.
    Date Received
    October 18, 1990
    Decision Date
    January 8, 1991
    Product Code
    DTB
    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
    DTB Permanent Pacemaker Electrode

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    Other Clearances by Telectronics Pacing Systems, Inc.

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    K910112 BIFURCATED VS-1 TO VS-1 LEAD ADAPTOR
    K903186 OPTIMA SERIES II MODEL 147B SINGLE CHAMBER PULSE
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