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

    SYNCRUS INTERNAL CARDIOVERSION SYSTEM

    K Number: K020701 · Decision May 24, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    1
    Applicant Total
    8
    Review Days
    81

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    SYNCRUS INTERNAL CARDIOVERSION SYSTEM
    K Number
    K020701
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3680
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Guidant Corporation, Cardiac Surgery
    Date Received
    March 4, 2002
    Decision Date
    May 24, 2002
    Product Code
    NHW
    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
    NHW Electrode, Pacing And Cardioversion, Temporary, Epicardial

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (NHW), ordered by most recent decision date.

    GUIDANT SYNCRUS INTERNAL CARDIOVERSION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all

    Other Clearances by Guidant Corporation, Cardiac Surgery

    K Number Device Name
    K080169 HEARTSTRING III PROXIMAL SEAL SYSTEM
    K041340 GUIDANT MICROWAVE ABLATION SYSTEM
    K023630 ESSEX ASPIRATION/IRRIGATION INSTRUMENT WITH POSITIONING GUIDE, MODEL SY-1400
    K024071 GUIDANT SYNCRUS INTERNAL CARDIOVERSION SYSTEM
    K023629 ESSEX DISSECTION CANNULA, MODEL SXD-1100, ESSEX DISSECTION TIP, MODEL SXD-1200
    K022718 VASOVIEW 6 HARVESTING CANNULA, MODELS VH-2000, VH-2001 & VH-2002
    K020143 VASOVIEW 5 HARVESTING CANNULA