FDA Registration
Active
🇮🇪 Ireland
Flextome Cutting Balloon Microsurgical Dilatation Device
Reg #: 9681260
·
FEI: 3002806565
·
Expires 2025
Products
6
Proprietary Names
2
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- Boston Scientific Limited
- Registration Number
- 9681260
- FEI Number
- 3002806565
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- BALLYBRIT BUSINESS PARK
- City
- GALWAY
- Country
- IE
Regulatory Submissions
- 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 protected]
- Phone
- 651 3961414
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheters, Transluminal Coronary Angioplasty, Percutaneous | LOX | Class 2 | Cardiovascular | No | 2000-05-18 |
| Stent, Renal | NIN | Class 3 | Unknown | No | 2000-05-18 |
| Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring | NWX | Class 3 | Unknown | No | 2000-05-18 |
| Coronary Drug-Eluting Stent | NIQ | Class 3 | Unknown | No | 2000-05-18 |
| Stent, Coronary | MAF | Class 3 | Unknown | No | 2000-05-18 |
| Catheter, Angioplasty, Peripheral, Transluminal | LIT | Class 2 | Cardiovascular | No | 2000-05-18 |
Proprietary Names
Flextome Cutting Balloon Microsurgical Dilatation Device
Wolverine Coronary Cutting Balloon Microsurgical Dilatation Device
Establishment Types
Manufacture Medical Device