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

    HARMAC THERMODILUTION CATHETER

    K Number: K963336 · Decision Aug 14, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Same Product Code
    98
    Applicant Total
    8
    Review Days
    412

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    Basic Information

    Device Name
    HARMAC THERMODILUTION CATHETER
    K Number
    K963336
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1240
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Harmac Medical Products, Inc.
    Date Received
    June 28, 1996
    Decision Date
    August 14, 1997
    Product Code
    DYG
    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
    DYG Catheter, Flow Directed

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    Other Clearances by Harmac Medical Products, Inc.

    K Number Device Name
    K021916 HARMAC HUBER NEEDLE SAFETY DEVICE, H2984001
    K963335 HARMAC BALLOON WEDGE PRESSURE CATHETER
    K962829 HARMAC BALLOON ANGIOGRAPHIC CATHETER
    K962833 HARMAC TEMPORARY PACING CATHETER WITH BALLOON
    K963073 HARMAC BIPOLAR TEMPORARY PACING CATHETER WITH STYLET
    K963074 HARMAC QUADPOLAR MAPPING PACING CATHETER
    K950895 HARMAC EXTENSION INFUSION SET