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
- [email protected]
- Phone
- 651 3961414
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2008-01-10 |
| Catheter, Nephrostomy, General & Plastic Surgery | GBO | Class 1 | General, Plastic Surgery | No | 2005-08-01 |
| Cable, Transducer And Electrode, Patient, (Including Connector) | DSA | Class 2 | Cardiovascular | No | 2013-12-23 |
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2024-07-18 |
| Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | DTL | Class 2 | Cardiovascular | No | 2017-11-14 |
| Device, Vascular, For Promoting Embolization | KRD | Class 2 | Cardiovascular | No | 2013-11-20 |
| Catheter, Intravascular, Diagnostic | DQO | Class 2 | Cardiovascular | No | 2008-01-30 |
| Catheter, Continuous Flush | KRA | Class 2 | Cardiovascular | No | 2020-10-19 |
| Peripheral Mechanical Thrombectomy With Aspiration | QEW | Class 2 | Cardiovascular | No | 2020-10-19 |
| Accessories, Catheter | KGZ | Class 1 | General, Plastic Surgery | No | 1999-03-08 |
| Endoscopic Guidewire, Gastroenterology-Urology | OCY | Class 2 | Gastroenterology, Urology | No | 2017-11-14 |
| Wire, Guide, Catheter, Exempt | PTL | Class 2 | Cardiovascular | No | 2023-08-02 |
| Catheter, Peripheral, Atherectomy | MCW | Class 2 | Cardiovascular | No | 2012-09-24 |
| Temporary Carotid Catheter For Embolic Capture | NTE | Class 2 | Cardiovascular | No | 2007-07-26 |
| Radiographic Protective Glove | IWP | Class 1 | Radiology | No | 1992-07-22 |
| Catheter, Peritoneal | GBW | Class 1 | General, Plastic Surgery | No | 2006-03-10 |
| Catheter, Electrode Recording, Or Probe, Electrode Recording | DRF | Class 2 | Cardiovascular | No | 2022-06-30 |
| Stents, Drains And Dilators For The Biliary Ducts | FGE | Class 2 | Gastroenterology, Urology | No | 2008-01-11 |
| Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter | OAD | Class 3 | Unknown | No | 2016-02-25 |
| Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation | OAE | Class 3 | Unknown | No | 2016-02-25 |
| Cardiac Ablation Percutaneous Catheter | LPB | Class 3 | Unknown | No | 2008-01-14 |
| Tube, Drainage, Suprapubic | FFA | Class 2 | Gastroenterology, Urology | No | 2008-01-03 |
| Catheter, Nephrostomy | LJE | Class U | Unknown | No | 2008-01-03 |
| Stent, Ureteral | FAD | Class 2 | Gastroenterology, Urology | No | 2008-01-03 |
| Catheter, Steerable | DRA | Class 2 | Cardiovascular | No | 2023-05-08 |
| Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation | QZI | Class 3 | Unknown | No | 2024-01-31 |
| Agents, Embolic, For Treatment Of Uterine Fibroids | NAJ | Class 2 | Cardiovascular | No | 2012-12-13 |
| Syringe, Balloon Inflation | MAV | Class 2 | Cardiovascular | No | 2014-09-26 |
| Cable, Electrode | IKD | Class 2 | Physical Medicine | No | 1992-08-27 |
| Stylet For Catheter, Gastro-Urology | EZB | Class 1 | Gastroenterology, Urology | No | 2002-01-15 |
| Needle, Catheter | GCB | Class 1 | General, Plastic Surgery | No | 1983-09-09 |
| Syringe, Balloon Inflation, Exempt | PTM | Class 2 | Cardiovascular | No | 2018-05-08 |
| Catheter, Intravascular Occluding, Temporary | MJN | Class 2 | Cardiovascular | No | 2013-11-13 |
| Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection | NFA | Class 2 | Cardiovascular | No | 2004-02-27 |
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