FDA Registration
Active
🇨🇷 Costa Rica
Rotaglide Lubricant
Reg #: 3004859241
·
FEI: 3004859241
·
Expires 2025
Products
1
Proprietary Names
14
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- BOSTON SCIENTIFIC CORPORATION
- Registration Number
- 3004859241
- FEI Number
- 3004859241
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 302 Parkway, Global Park
- City
- La Aurora Heredia
- Country
- CR
Regulatory Submissions
- 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
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 |
|---|---|---|---|---|---|
| Catheter, Coronary, Atherectomy | MCX | Class 3 | Unknown | No | 2008-01-22 |
Proprietary Names
Rotaglide Lubricant
RotaLink Plus Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device
Rotablator Dynaglide Foot Pedal
wireClip Torquer
ROTAPRO Rotational Atherectomy System Console Kit
ROTAPRO Advancer Burr Advancing Device
ROTAPRO Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device
RotaWire and wireClip Torquer Extra Support
ROTAWIRE Drive and wireClip Torquer Extra Support
RotaWire and wireClip Torquer Floppy
Rotablator Rotational Atherectomy System Console Kit
RotaLink Advancer Catheter Advancing Device
ROTAWIRE Drive and wireClip Torquer Floppy
RotaLink Burr Exchangeable Burr Catheter
Establishment Types
Manufacture Medical Device