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

    CPS DIRECT MEDIGUIDE ENABLED OUTER CATHETER

    K Number: K120296 · Decision May 11, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    276
    Registration Numbers
    277
    Same Product Code
    889
    Applicant Total
    10
    Review Days
    101

    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
    CPS DIRECT MEDIGUIDE ENABLED OUTER CATHETER
    K Number
    K120296
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    St. Jude Medical, Cardiac Rhythm Management Divisi
    Date Received
    January 31, 2012
    Decision Date
    May 11, 2012
    Product Code
    DQY
    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
    DQY Catheter, Percutaneous

    Similar 510(k) Clearances

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

    Amplatzer TorqVue Exchange System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Perfect-O Ostial Positioning Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Amplatzer TorqVue Delivery System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Teleport Glide Microcatheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Amplatzer™ Trevisio™ Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48)

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

    Other Clearances by St. Jude Medical, Cardiac Rhythm Management Divisi

    K Number Device Name
    K122090 SJM CONFIRM IMPLANTABLE CARDIAC MONITOR
    K120298 CPS EXCEL MEDIGUIDE ENABLED GUIDEWIRE
    K111943 AGILLS PF DELIVERY SYSTEM
    K103250 CPS DIRECT SL II SLITTABLE OUTER CATHETER
    K093858 PSA CABLE, MODELS 4160 AND 4161 AND PSA CABLE ADAPTER, MODEL 4053A
    K092075 CPS DIRECT SL II SLITTABLE OUTER CATHETER, MODELS DS2C001, DS2C002, DS2C003, DS2C004, DS2C005
    K090613 CPS AIM SL SLITTABLE INNER CATHETERS, MODELS DS2N021-59, DS2N022-59, DS2NO23-59, DS2N024-65, DS2N024-65, DS2N021-65, DS2
    K080924 MOND RVOT STYLET MODELS 4140, 4141, 4150, 4151
    K072864 ST. JUDE MEDICAL, CPS DUO LEFT HEART LEAD DELIVERY SYSTEM