BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BOSTON SCIENTIFIC CORPORATION

    Reg #: 2134265 · FEI: 3002095335 · Expires 2026
    View on FDA
    Products
    45
    Proprietary Names
    35
    Establishment Types
    3
    Classifications
    45

    Registration Details

    Registration Name
    BOSTON SCIENTIFIC CORPORATION
    Registration Number
    2134265
    FEI Number
    3002095335
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    Two Scimed Place
    City
    Maple Grove
    State
    MN
    ZIP
    55311
    Country
    US

    Regulatory Submissions

    510(k) Number
    K121196
    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

    Products

    Device Name Product Code
    Catheter, Coronary, Atherectomy MCX
    Catheters, Transluminal Coronary Angioplasty, Percutaneous LOX
    Coronary Drug-Eluting Stent NIQ
    Transmitters And Receivers, Physiological Signal, Radiofrequency DRG
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Computer, Diagnostic, Programmable DQK
    Transducer, Ultrasonic, Diagnostic ITX
    Computer, Blood-Pressure DSK
    Stent, Superficial Femoral Artery NIP
    Peripheral Mechanical Thrombectomy With Aspiration QEW
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Unit, Cryosurgical, Accessories GEH
    Catheter, Percutaneous DQY
    Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter OOB
    Stent, Renal NIN
    Device, Vascular, For Promoting Embolization KRD
    Catheter, Angioplasty, Peripheral, Transluminal LIT
    Stents, Drains And Dilators For The Biliary Ducts FGE
    Mechanical Thrombolysis Catheter QEY
    Catheter, Continuous Flush KRA
    Stent, Superficial Femoral Artery, Drug-Eluting NIU
    Catheter, Ultrasound, Intravascular OBJ
    Catheter, Intravascular, Diagnostic DQO
    Aspiration Thrombectomy Catheter QEZ
    Catheter, Peripheral, Atherectomy MCW
    System, Image Processing, Radiological LLZ
    Shield, Protective, Personnel KPY
    Device, Neurovascular Embolization HCG
    Introducer, Catheter DYB
    Wire, Guide, Catheter DQX
    Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue OCL
    Stent, Coronary MAF
    System, Appendage Closure, Left Atrial NGV
    Temporary Carotid Catheter For Embolic Capture NTE
    Agents, Embolic, For Treatment Of Uterine Fibroids NAJ
    Stent, Iliac NIO
    Transducer, Pressure, Catheter Tip DXO
    System, Applicator, Radionuclide, Manual IWJ
    Echocardiograph DXK
    Drug-Eluting Peripheral Transluminal Angioplasty Catheter ONU
    Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures PUM
    Microspheres Radionuclide NAW
    Intracranial Neurovascular Stent NJE
    Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia NOY
    Stand, Infusion FOX

    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 SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System SYNERGY XD Everolimus-Eluting Platinum Chromium Coronary Stent System SYNERGY MEGATRON Everolimus-Eluting Platinum Chromium Coronary Stent System AGENT Paclitaxel-Coated Balloon Catheter Express SD Renal/Biliary Premounted Stent System ELUVIA Drug-Eluting Vascular Stent System Innova Vascular Self-Expanding Stent System Guidezilla II PV Guide Extension Catheter REBEL Platinum Chromium Coronary Stent System WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System WATCHMAN FLX Pro Left Atrial Appendage Closure Device with Delivery System Ranger Paclitaxel-Coated PTA Balloon Catheter TheraSphereY-90 Glass Microspheres Gateway PTA Dilatation Catheter Emerge Push PTCA Dilatation Catheter Emerge PTCA Dilatation Catheter NC Emerge PTCA Dilatation Catheter AngioJet Ultra 5000A Console AngioJet Spiroflex Thrombecotmy Set AngioJet Spiroflex VG Thrombectomy Set AutoElite Thrombectomy System Console

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Manufacture Device in the United States for Export Only