| Proprietary Name: |
Guidewire and Guidewire Manipulation Device; Peripheral RotaLink Plus; Peripheral RotaWire Guidewire and wireClip Torquer; Pre-Connected Exchange Burr Catheter and Burr Advancing Device; Rotablator; Rotational Atherectomy System; Rotational Atherectomy System Console with Dynaglide Foot Pedal |
| Classification Name: |
CATHETER, PERIPHERAL, ATHERECTOMY |
| Product Code: |
MCW |
| Device Class: |
2 |
| Regulation Number: |
870.4875 |
| Medical Specialty: |
Cardiovascular |
| Registered Establishment Name: |
Boston Scientific Cork Limited
|
| Registered Establishment Number: |
9616684
|
| Owner/Operator: |
Boston Scientific Corporation |
| Owner/Operator Number: |
9912058
|
| Establishment Operations: |
Manufacturer
|
