| Proprietary Name: |
Emerge Monorail PTCA Dilatation Catheter; Emerge Over-The-Wire PTCA Dilatation Catheter; Emerge Push Monorail PTCA Dilatation Catheter; Emerge Push Over-The-Wire PTCA Dilatation Catheter; Gateway Monorail |
| Classification Name: |
CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS |
| Product Code: |
LOX |
| Device Class: |
2 |
| Regulation Number: |
870.5100 |
| Medical Specialty: |
Cardiovascular |
| Registered Establishment Name: |
BOSTON SCIENTIFIC CORPORATION
|
| Registered Establishment Number: |
2134265
|
| Owner/Operator: |
Boston Scientific Corporation |
| Owner/Operator Number: |
9912058
|
| Establishment Operations: |
U.S. Manufacturer of Export Only Devices
|
