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

    TRACFINDER II

    K Number: K924108 · Decision Dec 16, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    184
    Applicant Total
    15
    Review Days
    489

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    Basic Information

    Device Name
    TRACFINDER II
    K Number
    K924108
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1220
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ep Technologies, Inc.
    Date Received
    August 14, 1992
    Decision Date
    December 16, 1993
    Product Code
    DRF
    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
    DRF Catheter, Electrode Recording, Or Probe, Electrode Recording

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    Other Clearances by Ep Technologies, Inc.

    K Number Device Name
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    K940168 DIAGNOSTIC II CATHETER
    K924109 STEEROCATH II
    K913375 TORQUE TUBE STEEROCATH(TM)
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