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

    HEARTSTRING III PROXIMAL SEAL SYSTEM

    K Number: K080169 · Decision Feb 8, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    186
    Registration Numbers
    186
    Same Product Code
    203
    Applicant Total
    8
    Review Days
    15

    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
    HEARTSTRING III PROXIMAL SEAL SYSTEM
    K Number
    K080169
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4450
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Guidant Corporation, Cardiac Surgery
    Date Received
    January 24, 2008
    Decision Date
    February 8, 2008
    Product Code
    DXC
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DXC Clamp, Vascular

    Similar 510(k) Clearances

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

    Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Arc Adjustable Radial Cuff Compression Device

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Life Saving Tourniquet

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Radial Compression Device

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

    Other Clearances by Guidant Corporation, Cardiac Surgery

    K Number Device Name
    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
    K020701 SYNCRUS INTERNAL CARDIOVERSION SYSTEM
    K020143 VASOVIEW 5 HARVESTING CANNULA