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

    BIFLEX(TM) ANNULOPLASTY RING

    K Number: K902159 · Decision Jan 18, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    74
    Applicant Total
    23
    Review Days
    248

    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
    BIFLEX(TM) ANNULOPLASTY RING
    K Number
    K902159
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    St. Jude Medical, Inc.
    Date Received
    May 15, 1990
    Decision Date
    January 18, 1991
    Product Code
    KRH
    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
    KRH Ring, Annuloplasty

    Similar 510(k) Clearances

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

    MEMO 4D Curve™ Semirigid mitral annuloplasty ring

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TriMemo™ SEMIRIGID ANNULOPLASTY RING

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Seguin Annuloplasty Ring

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Edwards MC3 Tricuspid annuloplasty ring (4900)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Carpentier-Edwards Physio Annuloplasty Ring (4450)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TransForm McCarthy Mitral Annuloplasty Ring (TF)

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

    Other Clearances by St. Jude Medical, Inc.

    K Number Device Name
    K172393 Advisor HD Grid Mapping Catheter, Sensor Enabled
    K163407 Confirm Rx Insertable Cardiac Monitor (ICM) System
    K161171 PressureWire X Guidewire
    K161102 Nanostim Introducer Kit
    K160716 The Nanostim Introducer Kit
    K140793 NANOSTIM INTRODUCER KIT
    K133481 SJM CONFIRM IMPLANTABLE CARDIAC MONITOR (ICM)
    K131592 ENLIGHTN RENAL GUIDE CATHETER
    K073700 6F PROXIS SYSTEM
    K042734 SJM RIGID SADDLE RING MODEL RSAR-(SIZE)
    Search all 23 clearances from St. Jude Medical, Inc. →