BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    Boston Scientific Limited

    Reg #: 9616684 · FEI: 3002913962 · Expires 2026
    View on FDA
    Products
    31
    Proprietary Names
    14
    Establishment Types
    1
    Classifications
    31

    Registration Details

    Registration Name
    Boston Scientific Limited
    Registration Number
    9616684
    FEI Number
    3002913962
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Business and Technology Park, Model Farm Road
    City
    CORK Munster
    Country
    IE

    Regulatory Submissions

    510(k) Number
    K140273
    PMA Number
    P900056

    Owner / Operator

    Firm Name
    Boston Scientific Corporation
    Operator Number
    9912058
    Address
    300 Boston Scientific Way
    City
    Marlborough
    State
    MA
    Postal Code
    01752
    Country
    US

    US Agent

    Business Name
    Boston Scientific Corporation
    Contact Name
    Aaron Dunbar
    Address
    300 Boston Scientific Way
    City
    Marlborough
    State
    MA
    ZIP
    01752
    Country
    US
    Email
    [email protected]
    Phone
    651 3961414

    Products

    Device Name Product Code
    Catheter, Intravascular Occluding, Temporary MJN
    Catheter, Intravascular, Diagnostic DQO
    Stents, Drains And Dilators For The Biliary Ducts FGE
    Bronchoscope Accessory KTI
    Catheter, Peripheral, Atherectomy MCW
    Peripheral Mechanical Thrombectomy With Aspiration QEW
    Syringe, Balloon Inflation MAV
    Device, Vascular, For Promoting Embolization KRD
    Dilator, Esophageal KNQ
    Accelerator, Linear, Medical IYE
    Endoscope Channel Accessory ODC
    Catheter, Continuous Flush KRA
    Syringe, Balloon Inflation, Exempt PTM
    Endoscopic Irrigation/Suction System OCX
    Agents, Embolic, For Treatment Of Uterine Fibroids NAJ
    Device, Neurovascular Embolization HCG
    Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia NOY
    Colonoscope And Accessories, Flexible/Rigid FDF
    Duodenoscope And Accessories, Flexible/Rigid FDT
    Hydrogel Spacer OVB
    Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass DTL
    Wire, Guide, Catheter DQX
    Catheter, Ureteral, Gastro-Urology EYB
    Accessories, Cleaning Brushes, For Endoscope MNL
    Catheter, Percutaneous DQY
    Wire, Guide, Catheter, Exempt PTL
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Unit, Electrosurgical, Endoscopic (With Or Without Accessories) KNS
    Lavage, Jet FQH
    Catheter, Coronary, Atherectomy MCX
    Powered Laser Surgical Instrument GEX

    Proprietary Names

    RotaLink Plus Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device Rotaglide Lubricant Rotablator Dynaglide Foot Pedal wireClip Torquer ROTAPRO Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device ROTAPRO Advancer Burr Advancing Device ROTAPRO Rotational Atherectomy System Console Kit ROTAWIRE Drive and wireClip Torquer Floppy RotaWire and wireClip Torquer Extra Support RotaLink Advancer Catheter Advancing Device RotaWire and wireClip Torquer Floppy Rotablator Rotational Atherectomy System Console Kit RotaLink Burr Exchangeable Burr Catheter ROTAWIRE Drive and wireClip Torquer Extra Support

    Establishment Types

    Manufacture Medical Device