BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    Boston Scientific Limited

    Reg #: 9681260 · FEI: 3002806565 · Expires 2026
    View on FDA
    Products
    108
    Proprietary Names
    154
    Establishment Types
    2
    Classifications
    108

    Registration Details

    Registration Name
    Boston Scientific Limited
    Registration Number
    9681260
    FEI Number
    3002806565
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    BALLYBRIT BUSINESS PARK
    City
    GALWAY
    Country
    IE

    Regulatory Submissions

    510(k) Number
    K101314
    PMA Number
    P950020

    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
    Stents, Drains And Dilators For The Biliary Ducts FGE
    Catheter, Intravascular Occluding, Temporary MJN
    Catheter, Angioplasty, Peripheral, Transluminal LIT
    Pump, Air, Non-Manual, For Endoscope FEQ
    Catheters, Transluminal Coronary Angioplasty, Percutaneous LOX
    Catheter, Continuous Flush KRA
    Stent, Coronary MAF
    Coronary Drug-Eluting Stent NIQ
    Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring NWX
    Stent, Renal NIN
    Catheter, Percutaneous DQY
    Catheter, Coronary, Atherectomy MCX
    Laparoscope, General & Plastic Surgery GCJ
    Catheter, Cholangiography GBZ
    Endoscopic Cytology Brush FDX
    Catheter, Electrode Recording, Or Probe, Electrode Recording DRF
    Unit, Electrosurgical, Endoscopic (With Or Without Accessories) KNS
    Peripheral Mechanical Thrombectomy With Aspiration QEW
    Dilator, Catheter, Ureteral EZN
    Gastrointestinal Tubes With Enteral Specific Connectors PIF
    Wire, Guide, Catheter DQX
    Choledochoscope And Accessories, Flexible/Rigid FBN
    Camera, Surgical And Accessories KQM
    Led Light Source NTN
    Aspiration Thrombectomy Catheter QEZ
    Prosthesis, Esophageal ESW
    Endoscope Channel Accessory ODC
    Endoscopic Guidewire, Gastroenterology-Urology OCY
    Tubes, Gastrointestinal (And Accessories) KNT
    Device, Vascular, For Promoting Embolization KRD
    Ureteroscope And Accessories, Flexible/Rigid FGB
    Stent, Ureteral FAD
    Endoscopic Injection Needle, Gastroenterology-Urology FBK
    Cable, Electrode IKD
    Catheter, Intravascular, Diagnostic DQO
    Tube, Drainage, Suprapubic FFA
    Stent, Iliac NIO
    Shunt, Portosystemic, Endoprosthesis MIR
    Needle, Catheter GCB
    Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss QTD
    Dislodger, Stone, Biliary LQR
    Dilator, Urethral KOE
    Duodenoscope And Accessories, Flexible/Rigid FDT
    Endoscopic Video Imaging System/Component, Gastroenterology-Urology FET
    Endoscopic Ultrasound System, Gastroenterology-Urology ODG
    Biopsy Needle FCG
    Prosthesis, Tracheal, Expandable JCT
    Colonoscope And Accessories, Flexible/Rigid FDF
    Dilator, Esophageal KNQ
    Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse PWI
    Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula ODD
    Catheter, Percutaneous, Cutting/Scoring PNO
    Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator OTN
    Instrument, Manual, Surgical, General Use MDM
    Lithotriptor, Biliary Mechanical LQC
    Intracranial Neurovascular Stent NJE
    Introducer, Catheter DYB
    Bronchoscope (Flexible Or Rigid) EOQ
    Endoscopic Access Overtube, Gastroenterology-Urology FED
    Catheter, Urological KOD
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    System, Appendage Closure, Left Atrial NGV
    Lithotriptor, Electro-Hydraulic FFK
    Hemostatic Metal Clip For The Gi Tract PKL
    Catheter, Nephrostomy, General & Plastic Surgery GBO
    Snare, Flexible FDI
    Cable, Transducer And Electrode, Patient, (Including Connector) DSA
    Bronchoscope Accessory KTI
    Endoscopic Cholangiogram Kit NWT
    Mechanical Thrombolysis Catheter QEY
    Biliary Stent System For Benign Strictures PNB
    Snare, Non-Electrical FGX
    Endoscopic Tissue Approximation Device OCW
    Stent, Carotid NIM
    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter OAD
    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation OAE
    Powered Laser Surgical Instrument GEX
    Stent, Colonic, Metallic, Expandable MQR
    Stent, Metallic, Expandable, Duodenal MUM
    Stent, Central Venous QKJ
    Stent, Iliac Vein QAN
    Medical Glove, Specialty LZC
    Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation QZI
    Catheter, Steerable DRA
    Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection GCA
    Radiographic Protective Glove IWP
    Brush, Biopsy, Bronchoscope (Non-Rigid) BTG
    Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling PAH
    Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass DTL
    Catheter, Nephrostomy LJE
    Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter OOB
    Cardiac Ablation Percutaneous Catheter LPB
    Stylet For Catheter, Gastro-Urology EZB
    Stent, Superficial Femoral Artery, Drug-Eluting NIU
    Pancreatic Stent, Covered, Metallic, Removable PCU
    Accessories, Catheter KGZ
    Transducer, Pressure, Catheter Tip DXO
    Syringe, Balloon Inflation MAV
    Prosthesis, Penile FAE
    Stent, Superficial Femoral Artery NIP
    Endoscopic Irrigation/Suction System OCX
    Lavage, Jet FQH
    Catheter, Urethral GBM
    Forceps, Biopsy, Non-Electric FCL
    Syringe, Balloon Inflation, Exempt PTM
    Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt PTS
    Drug-Eluting Peripheral Transluminal Angioplasty Catheter ONU
    Syringe, Irrigating (Non Dental) KYZ

    Proprietary Names

    Wolverine Coronary Cutting Balloon Microsurgical Dilatation Device Flextome Cutting Balloon Microsurgical Dilatation Device AngioJet Ultra 5000A Console AngioJet Spiroflex Thrombecotmy Set AngioJet Spiroflex VG Thrombectomy Set AutoElite Thrombectomy System Console WALLSTENT RP Endoprosthesis Self-Expanding Stent 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 Trapezoid RX Wireguided Retrieval Basket WALLSTENT Endoprosthesis Self-Expanding Stent WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System WATCHMAN FLX Pro Left Atrial Appendage Closure Device with Delivery System Promus ELITE Everolimus-Eluting Platinum Chromium Coronary Stent System Flexima Nephrostomy Catheter System Kit Flexima Nephrostomy Catheter System TLA Introducer Needle and Sheath Set Percutaneous Access Needle Percuflex Locking Loop with Fader Tip Nephrostomy Catheter Kit Malecot Nephrostomy Catheter Set Flexima Nephrostomy Catheter System Kit with Dissolving Tip Flexima Nephrostomy Catheter System with Dissolving Tip JINRO Pigtail Nephrostomy Catheter Kit Percuflex Locking Loop Nephrostomy Catheter with Fader Tip Re-entry Malecot Nephrostomy Catheter Set Percuflex Locking Loop All Purpose Drainage Catheter with Fader Tip Expel Drainage Catheter with Twist-Loc Hub Nephrostromy Drainage Catheter Percutaneous Access Needle with Echogenic Tip JINRO Pigtail Nephrostomy Catheter Placement Kit JINRO Pigtail Nephrostomy Catheter Percuflex Locking Loop Nephrostomy Catheter VTC Nephrostomy Catheters System Kit VTC Nephrostomy Catheters System Expel Drainage Catheter with Twist-Loc Hub Nephrostromy Drainage Catheter Kit Percutaneous Access Set NaviGuide Percutaneous Access Needle REBEL Platinum Chromium Coronary Stent System Carotid WALLSTENT Monorail Endoprosthesis Cable, Maestro 4000 Blazer Open-Irrigated Ablation Catheter MetriQ Irrigation Tubing Set Open-Irrigation Tubing Set MetriQ Foot Switch MetriQ Pump Irrigation Pump IntellaNav Open-Irrigated Ablation Catheter IntellaTip MiFi Open-Irrigated Ablation Catheter IntellaNav MiFi Open-Irrigated Ablation Catheter Rhythmia Mapping System IntellaNav CB - Maestro Rhythmia HDx Ablation Connection Box Maestro RHYTHMIA HDx Ablation Connection Box – IntellaNav StablePoint INTELLAGEN Serial Communication Cable 5 Meter INTELLAGEN Irrigation Pump Connection Cable 3 Meter INTELLAGEN Serial Communication Cable 3 Meter INTELLAGEN Serial Communication Cable 15 Meter INTELLAGEN Catheter Adapter Cable 0.3 Meter INTELLAGEN Foot Pedal INTELLAGEN Remote Control Kit INTELLAGEN Remote Control Connection Cable 25 Meter INTELLAGEN Remote Control Connection Cable 10 Meter Cable, IntellaNav Ablation Catheter Rhythmia HDx Ablation Connection Box - for INTELLAGEN INTELLAGEN ECG Connection Cable 3 Meter INTELLAGEN Grounding Cable 3 Meter INTELLAGEN Irrigation Pump Connection Cable 10 Meter INTELLAGEN Remote Control Connection Cable 30 Meter IntellaNav StablePoint Catheter Cable Rhythmia HDx Ablation Connection Box - IntellaNav StablePoint - for INTELLAGEN INTELLAGEN RF Generator Kit INTELLAGEN Irrigation Pump Kit INTELLAGEN Tubing Set Cable IntellaTip MiFi OI to Maestro 4000 IntellaNav StablePoint Ablation Catheter INTELLAGEN Remote Control Connection Cable 15 Meter Cable, IntellaTip MiFi OI INTELLAGEN Irrigation Pump Connection Cable 1 Meter INTELLAGEN Foot Pedal Extension Cable 7 Meter INTELLAGEN Irrigation Pump Connection Cable 5 Meter Express SD Renal/Biliary Premounted Stent System VENOUS WALLSTENT Self-Expanding Stent FARASTAR IEC Recording System Module ECG Output Module FARASTAR Stimulation Module Male Cable FARASTAR IEC Recording System Module ECG Trunk Cable FARASTAR AAMI Recoding System Module ECG Output Module FARASTAR AAMI Snap Cable R/L FARASTAR Recording System Module FARASTAR Catheter Connection Cable FARASTAR IEC Snap Cable C Set FARAWAVE Pulsed Field Ablation Catheter FARASTAR Mapping System Module FARASTAR Stimulation Module Cable FARASTAR Stimulation Module Y-Cable Short FARASTAR Stimulation Module Y-Cable Long FARASTAR Cable Set FARAWAVE Nav Pulsed Field Ablation Catheter FARASTAR Mapping System Module BNC-Phono Cable FARASTAR EGM Cable FARASTAR Mapping System Module Back Patch Cable Male FARASTAR Gen 2 Catheter Connection Cable FARASTAR Recording System Module ECG Output to Signal Station ECG Input Cable FARASTAR to OPAL HDx FARASTAR Stimulation Module Female Cable FARASTAR Inter-Connection Box FARASTAR EGM to EP Recording System Cable (FARAPOINT) FARASTAR Mapping System Module Auxiliary Cable FARASTAR AAMI Snap Cable V Set FARASTAR Mapping System Module Back Patch Cable FARASTAR Pulsed Field Ablation Generator FARASTAR IEC Snap Cable R/L FARASTAR Mapping System Module ABL Output to Signal Station ABL Input Cable FARASTAR to OPAL HDx FARASTAR AAMI Recording System Module ECG Trunk Cable FARASTAR Recording System Module EGM Input Module FARASTAR Recording System Module Catheter Pin Cable FARAPOINT Pulsed Field Ablation Catheter FARASTAR Recording System Module EGM Output to Singal Station EGM Input Cable FARASTAR to OPAL HDx AGENT Paclitaxel-Coated Balloon Catheter Cable IntellaTip MiFi XP Sterile Cable IntellaTip MiFi Reference Cable Non-Sterile Electrophysiology Cable IntellaTip MiFi Filter Module RF Frequency Filter IntellaTip MiFi XP Temperature Ablation Catheter Blazer Prime XP Temperature Ablation Catheter IntellaNav MiFi XP Temperature Ablation Catheter Electrophysiology Cable Non-Sterile Cable Blazer Solid-Tip Ablation Cather Cable, Sterile Cable Maestro 4000 RF Cardiac Ablation Controller Maestro 4000 RF Cardiac Ablation Pod 100 Maestro Foot Switch IntellaNav XP Temperature Ablation Catheter Maestro 4000 Remote Control Rhythmia HDx Ablation Connection Box Blazer II XP Temperature Ablation Catheter Non-Sterile Cable ELUVIA Drug-Eluting Vascular Stent System Epic Vascular Self-Expanding Stent System Innova Vascular Self-Expanding Stent System Electrophysiology Cable Sterile Cable Maestro 4000 Controller, RF Cardiac Ablation Controller Blazer Prime HTD Temperature Ablation Catheter Maestro 4000 Pod, 100W, RF Cardiac Ablation Pod, 100W IntellaNav ST Ablation Catheter Blazer II HTD Temperature Ablation Catheter Blazer II Temperature Ablation Catheter Blazer Solid-Tip Ablation Catheter Cable, Sterile Cable Maestro Remote Control Cable Non-Sterile Cable (Controller to Pump or Remote Control) Express LD Iliac/Biliary Stent System SMARTFREEZE Cryo-Cable SMARTFREEZE Catheter Extension Cable SMARTFREEZE Cryo-Console SMARTFREEZE Inter-Connection Box SMARTFREEZE Cryo-Console Foot Switch POLARx Cryoablation Balloon Catheter SMARTFREEZE Remote Control POLARx FIT Cryoablation Balloon Catheter SMARTFREEZE Diaphragm Movement Sensor Ranger Paclitaxel-Coated PTA Balloon Catheter

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility