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

    HARMAC QUADPOLAR MAPPING PACING CATHETER

    K Number: K963074 · Decision Jun 25, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    184
    Applicant Total
    8
    Review Days
    362

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    Basic Information

    Device Name
    HARMAC QUADPOLAR MAPPING PACING CATHETER
    K Number
    K963074
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1220
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Harmac Medical Products, Inc.
    Date Received
    June 28, 1996
    Decision Date
    June 25, 1997
    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 Harmac Medical Products, Inc.

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    K963073 HARMAC BIPOLAR TEMPORARY PACING CATHETER WITH STYLET
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