| Proprietary Name: |
Apex Flex Monorail PTCA Dilatation Catheter; Apex Flex Over-the-Wire Monorail PTCA Dilatation Catheter; Apex Monorail PTCA Dilatation Catheter; Apex Over-the-Wire PTCA Dilatation Catheter; Apex Push Monorail PTCA Dilatation Catheter; Apex Push Over-the-Wire Monorail PTCA Dilatation Catheter; Maverick 2 Monorail PTCA Dilatation Catheter; Maverick Over-the-Wire PTCA Dilatation Catheter; Maverick XL Monorail PTCA Dilatation Catheter; NC Quantum Apex Monorail PTCA Dilatation Catheter; NC Quantum Apex Over-the-Wire PTCA Dilatation Catheter; Quantum Maverick Monorail PTCA Dilatation Catheter; Quantum Maverick Over-the-Wire PTCA Dilatation Catheter |
| 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 Corp., Marina Bay Cust. Fulfillment Center
|
| Registered Establishment Number: |
1225687
|
| Owner/Operator: |
Boston Scientific Corporation |
| Owner/Operator Number: |
9912058
|
| Establishment Operations: |
Repackager/Relabeler
|
