FDA Registration
Active
🇳🇱 Netherlands
Boston Scientific International BV, European Dist. Ctr.
Reg #: 3005111382
·
FEI: 3005111382
·
Expires 2026
Products
9
Proprietary Names
4
Establishment Types
1
Classifications
9
Registration Details
- Registration Name
- Boston Scientific International BV, European Dist. Ctr.
- Registration Number
- 3005111382
- FEI Number
- 3005111382
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- VERSTASTRAAT 6
- City
- KERKRADE Limburg
- Country
- NL
Regulatory Submissions
- 510(k) Number
- K180102
- PMA Number
- P940019
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 |
|---|---|---|---|---|---|
| Stent, Iliac | NIO | Class 3 | Unknown | No | 2008-01-22 |
| Stent, Coronary | MAF | Class 3 | Unknown | No | 2008-01-22 |
| Shunt, Portosystemic, Endoprosthesis | MIR | Class 3 | Unknown | No | 2008-01-22 |
| Device, Vascular, For Promoting Embolization | KRD | Class 2 | Cardiovascular | No | 2018-04-25 |
| Agents, Embolic, For Treatment Of Uterine Fibroids | NAJ | Class 2 | Cardiovascular | No | 2018-04-25 |
| Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia | NOY | Class 2 | Gastroenterology, Urology | No | 2018-04-25 |
| Drug-Eluting Peripheral Transluminal Angioplasty Catheter | ONU | Class 3 | Unknown | No | 2020-11-02 |
| Stent, Central Venous | QKJ | Class 3 | Unknown | No | 2008-01-22 |
| Stent, Iliac Vein | QAN | Class 3 | Unknown | No | 2008-01-22 |
Proprietary Names
WALLSTENT RP Endoprosthesis Self-Expanding Stent
WALLSTENT Endoprosthesis Self-Expanding Stent
Ranger Paclitaxel-Coated PTA Balloon Catheter
VENOUS WALLSTENT Self-Expanding Stent
Establishment Types
Manufacture Medical Device