FDA Registration Active 🇨🇷 Costa Rica

BOSTON SCIENTIFIC CORPORATION

Reg #: 3004859241 · FEI: 3004859241 · Expires 2026
Products
34
Proprietary Names
129
Establishment Types
2
Classifications
34

Registration Details

Registration Name
BOSTON SCIENTIFIC CORPORATION
Registration Number
3004859241
FEI Number
3004859241
Status
Active
Expiry Year
2026
Initial Importer
No
Address
302 Parkway, Global Park
City
La Aurora Heredia
Country
CR

Regulatory Submissions

510(k) Number
K944677
PMA Number
P150005

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
Phone
651 3961414

Products

Device Name Product Code
Wire, Guide, Catheter DQX
Catheter, Nephrostomy, General & Plastic Surgery GBO
Cable, Transducer And Electrode, Patient, (Including Connector) DSA
Catheter, Percutaneous DQY
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass DTL
Device, Vascular, For Promoting Embolization KRD
Catheter, Intravascular, Diagnostic DQO
Catheter, Continuous Flush KRA
Peripheral Mechanical Thrombectomy With Aspiration QEW
Accessories, Catheter KGZ
Endoscopic Guidewire, Gastroenterology-Urology OCY
Wire, Guide, Catheter, Exempt PTL
Catheter, Peripheral, Atherectomy MCW
Temporary Carotid Catheter For Embolic Capture NTE
Radiographic Protective Glove IWP
Catheter, Peritoneal GBW
Catheter, Electrode Recording, Or Probe, Electrode Recording DRF
Stents, Drains And Dilators For The Biliary Ducts FGE
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter OAD
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation OAE
Cardiac Ablation Percutaneous Catheter LPB
Tube, Drainage, Suprapubic FFA
Catheter, Nephrostomy LJE
Stent, Ureteral FAD
Catheter, Steerable DRA
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation QZI
Agents, Embolic, For Treatment Of Uterine Fibroids NAJ
Syringe, Balloon Inflation MAV
Cable, Electrode IKD
Stylet For Catheter, Gastro-Urology EZB
Needle, Catheter GCB
Syringe, Balloon Inflation, Exempt PTM
Catheter, Intravascular Occluding, Temporary MJN
Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection NFA

Proprietary Names

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 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 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 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) 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 HDx Ablation Connection Box Blazer II XP Temperature Ablation Catheter Non-Sterile Cable 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 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

Establishment Types

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