FDA Registration Active 🇺🇸 United States

Boston Scientific Corporation

Reg #: 1000121056 · FEI: 1000121056 · Expires 2026
Products
123
Proprietary Names
182
Establishment Types
2
Classifications
123

Registration Details

Registration Name
Boston Scientific Corporation
Registration Number
1000121056
FEI Number
1000121056
Status
Active
Expiry Year
2026
Initial Importer
No
Address
8 Industrial Dr
City
Coventry
State
RI
ZIP
02816
Country
US

Regulatory Submissions

510(k) Number
K232162
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
Unit, Electrosurgical, Endoscopic (With Or Without Accessories) KNS
Catheter, Continuous Flush KRA
Introducer, Catheter DYB
Ureteroscope And Accessories, Flexible/Rigid FGB
Lithotriptor, Electro-Hydraulic FFK
Wire, Guide, Catheter DQX
Device, Vascular, For Promoting Embolization KRD
Pancreatic Stent, Covered, Metallic, Removable PCU
Catheter, Electrode Recording, Or Probe, Electrode Recording DRF
Snare, Non-Electrical FGX
Snare, Flexible FDI
Catheter, Coronary, Atherectomy MCX
Cardiac Ablation Percutaneous Catheter LPB
Stents, Drains And Dilators For The Biliary Ducts FGE
Implantable Cardioverter Defibrillator (Non-Crt) LWS
Permanent Defibrillator Electrodes NVY
Coronary Drug-Eluting Stent NIQ
Catheter, Intravascular, Diagnostic DQO
Bronchoscope Accessory KTI
Electrosurgical, Cutting & Coagulation & Accessories GEI
Catheter, Percutaneous DQY
Stent, Ureteral FAD
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator OTN
Percutaneous Atrial Catheter Kit OFK
Peripheral Mechanical Thrombectomy With Aspiration QEW
Catheter, Angioplasty, Peripheral, Transluminal LIT
Catheters, Transluminal Coronary Angioplasty, Percutaneous LOX
Biopsy Needle FCG
Endoscopic Ultrasound System, Gastroenterology-Urology ODG
Endoscopic Cholangiogram Kit NWT
Aspiration Thrombectomy Catheter QEZ
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass DTL
Syringe, Balloon Inflation MAV
Shunt, Portosystemic, Endoprosthesis MIR
Pump, Air, Non-Manual, For Endoscope FEQ
Mechanical Thrombolysis Catheter QEY
Stent, Coronary MAF
Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring NWX
Stent, Renal NIN
Dislodger, Stone, Biliary LQR
Cable, Transducer And Electrode, Patient, (Including Connector) DSA
Adaptor, Bulbs, Miscellaneous, For Endoscope FFY
Catheter, Intravascular Occluding, Temporary MJN
Temporary Carotid Catheter For Embolic Capture NTE
Dislodger, Stone, Basket, Ureteral, Metal FFL
Stent, Iliac NIO
Endoscope Channel Accessory ODC
Catheter, Septostomy DXF
Catheter, Peripheral, Atherectomy MCW
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter OAD
Endoscopic Access Overtube, Gastroenterology-Urology FED
Prosthesis, Tracheal, Expandable JCT
Bronchoscope (Flexible Or Rigid) EOQ
Evacuator, Gastro-Urology KQT
Catheter, Urological KOD
Hemostatic Metal Clip For The Gi Tract PKL
Mesh, Surgical, For Stress Urinary Incontinence, Male OTM
Dilator, Esophageal KNQ
Gastrointestinal Tubes With Enteral Specific Connectors PIF
Stent, Colonic, Metallic, Expandable MQR
Stent, Metallic, Expandable, Duodenal MUM
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling PAH
Tubes, Gastrointestinal (And Accessories) KNT
Forceps, Biopsy, Non-Electric FCL
Choledochoscope And Accessories, Flexible/Rigid FBN
Camera, Surgical And Accessories KQM
Led Light Source NTN
Tube, Drainage, Suprapubic FFA
Catheter, Nephrostomy LJE
Colonoscope And Accessories, Flexible/Rigid FDF
Duodenoscope And Accessories, Flexible/Rigid FDT
Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence PWJ
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation QZI
Powered Laser Surgical Instrument GEX
Dilator, Catheter, Ureteral EZN
Laparoscope, General & Plastic Surgery GCJ
Medical Glove, Specialty LZC
Dilator, Vessel, For Percutaneous Catheterization DRE
Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed OTO
Catheter, Urethral GBM
Dilator, Urethral KOE
Transducer, Pressure, Catheter Tip DXO
Endoscopic Guidewire, Gastroenterology-Urology OCY
Syringe, Irrigating (Non Dental) KYZ
Endoscopic Cytology Brush FDX
Endoscopic Irrigation/Suction System OCX
Probe, Radiofrequency Lesion GXI
Lithotriptor, Biliary Mechanical LQC
Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt PTS
Endoscopic Tissue Approximation Device OCW
Needle, Catheter GCB
Stent, Superficial Femoral Artery NIP
Gynecological Laparoscopic Kit OHD
Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula ODD
Biliary Stent System For Benign Strictures PNB
Drug-Eluting Peripheral Transluminal Angioplasty Catheter ONU
Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss QTD
Prosthesis, Penile FAE
Lavage, Jet FQH
Instrument, Manual, Surgical, General Use MDM
Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection GCA
Stylet For Catheter, Gastro-Urology EZB
Dilator, Catheter GCC
Stent, Superficial Femoral Artery, Drug-Eluting NIU
Cable, Electrode IKD
Catheter, Cholangiography GBZ
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation OAE
Radiographic Protective Glove IWP
Intracranial Neurovascular Stent NJE
Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse PWI
Catheter, Steerable DRA
Brush, Biopsy, Bronchoscope (Non-Rigid) BTG
Stent, Central Venous QKJ
Stent, Iliac Vein QAN
Prosthesis, Esophageal ESW
Accessories, Catheter KGZ
Esophageal Dilator Balloon With Or Without Electrode Sensors PID
System, Appendage Closure, Left Atrial NGV
Catheter, Nephrostomy, General & Plastic Surgery GBO
Syringe, Balloon Inflation, Exempt PTM
Wire, Guide, Catheter, Exempt PTL
Endoscopic Injection Needle, Gastroenterology-Urology FBK
Endoscopic Video Imaging System/Component, Gastroenterology-Urology FET

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 Electrophysiology Cable Sterile Cable Maestro 4000 Controller, RF Cardiac Ablation Controller Blazer Prime HTD Temperature Ablation Catheter Maestro 4000 Remote Control Maestro 4000 Pod, 100W, RF Cardiac Ablation Pod, 100W Maestro Foot Switch IntellaNav ST Ablation Catheter Blazer II HTD Temperature Ablation Catheter Cable, IntellaNav Ablation Catheter Blazer II Temperature Ablation Catheter INTELLAGEN Foot Pedal INTELLAGEN Remote Control Connection Cable 10 Meter INTELLAGEN Remote Control Connection Cable 25 Meter INTELLAGEN Grounding Cable 3 Meter Blazer Solid-Tip Ablation Catheter Cable, Sterile Cable INTELLAGEN Serial Communication Cable 15 Meter INTELLAGEN Remote Control Connection Cable 30 Meter Maestro Remote Control Cable Non-Sterile Cable (Controller to Pump or Remote Control) INTELLAGEN Serial Communication Cable 3 Meter Rhythmia HDx Ablation Connection Box - for INTELLAGEN INTELLAGEN Remote Control Kit INTELLAGEN Catheter Adapter Cable 0.3 Meter INTELLAGEN Remote Control Connection Cable 15 Meter INTELLAGEN Serial Communication Cable 5 Meter INTELLAGEN RF Generator Kit INTELLAGEN Foot Pedal Extension Cable 7 Meter INTELLAGEN ECG Connection Cable 3 Meter ENDOTAK RELIANCE G Connector Tools Lead Repair Kit Lead Pulling Tip RELIANCE 4-FRONT Defibrillation Lead Suture Sleeve Accessory Lead Stylets Lead Adapter Lead Cap Kit ENDOTAK RELIANCE ENDOTAK RELIANCE SG ENDOTAK RELIANCE S 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 WALLSTENT RP Endoprosthesis Self-Expanding Stent WALLSTENT Endoprosthesis Self-Expanding Stent Wolverine Coronary Cutting Balloon Microsurgical Dilatation Device Flextome Cutting Balloon Microsurgical Dilatation Device Epic Vascular Self-Expanding Stent System 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 IntellaNav XP Temperature Ablation Catheter Rhythmia Mapping System IntellaNav CB - Maestro Rhythmia HDx Ablation Connection Box Blazer II XP Temperature Ablation Catheter Non-Sterile Cable Promus ELITE Everolimus-Eluting Platinum Chromium Coronary Stent System Endovive Securi-T Percutaneous Replacement Gastrostomy Tube 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 Trapezoid RX Wireguided Retrieval Basket AngioJet Ultra 5000A Console AngioJet Spiroflex Thrombecotmy Set AngioJet Spiroflex VG Thrombectomy Set AutoElite Thrombectomy System Console Innova Vascular Self-Expanding Stent System Ranger Paclitaxel-Coated PTA Balloon Catheter ELUVIA Drug-Eluting Vascular Stent System Express SD Renal/Biliary Premounted 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 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 HDx Ablation Connection Box Maestro RHYTHMIA HDx Ablation Connection Box – IntellaNav StablePoint INTELLAGEN Irrigation Pump Connection Cable 3 Meter INTELLAGEN Irrigation Pump Connection Cable 10 Meter IntellaNav StablePoint Catheter Cable Rhythmia HDx Ablation Connection Box - IntellaNav StablePoint - for INTELLAGEN INTELLAGEN Irrigation Pump Kit INTELLAGEN Tubing Set Cable IntellaTip MiFi OI to Maestro 4000 IntellaNav StablePoint Ablation Catheter Cable, IntellaTip MiFi OI INTELLAGEN Irrigation Pump Connection Cable 1 Meter INTELLAGEN Irrigation Pump Connection Cable 5 Meter VENOUS WALLSTENT Self-Expanding Stent WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System WATCHMAN FLX Pro Left Atrial Appendage Closure Device with Delivery System REBEL 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 Gateway PTA Dilatation Catheter Emerge Push PTCA Dilatation Catheter Emerge PTCA Dilatation Catheter NC Emerge PTCA Dilatation Catheter

Establishment Types

Manufacture Medical Device Manufacture Device in the United States for Export Only