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

    SWAN GANZ CATHETER PLACEMENT KIT

    K Number: K802288 · Decision Nov 20, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Same Product Code
    98
    Applicant Total
    19
    Review Days
    62

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    Basic Information

    Device Name
    SWAN GANZ CATHETER PLACEMENT KIT
    K Number
    K802288
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1240
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Stanco Medical, Inc.
    Date Received
    September 19, 1980
    Decision Date
    November 20, 1980
    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 Stanco Medical, Inc.

    K Number Device Name
    K810642 ATRIAL-VENTRICULAR PACING ELECTRODE KIT
    K810643 UNIVERSAL PACING ELECTRODE KIT
    K802289 PERICARDIOCENTESIS KIT
    K802287 RIGHT ATRIAL LINE KIT
    K802259 TRANSVENOUS PACEMAKER ELECTRODE KIT
    K802290 REGIONAL INTRAVENOUS ANESTHESIA KIT
    K802326 PRESSURE MONITORING LINES
    K802260 VASCULAR CATHETER WIREGUIDES
    K802328 DISP. TOUGY-BORST TYPE ADAPTOR W/PORT
    K802327 SHEATH DILATOR SET
    Search all 19 clearances from Stanco Medical, Inc. →