MOU · Intravascular Radiation Delivery System
· Class 3
Overview
| Product Code | MOU |
|---|---|
| Device Name | Intravascular Radiation Delivery System |
| Device Class | Class 3 |
| Review Panel |
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P000052 | GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM | Guidant Corp. | Nov 2, 2001 | APWD |
| P990036 | CORDIS CHECKMATE(TM) SYSTEM | Cordis Corp. | Nov 3, 2000 | APWD |
| P000018 | BETA-CATH (TM) SYSTEM | Best Vascular, Inc. | Nov 3, 2000 | APPR |
Top Applicants
- Best Vascular, Inc. — 1 clearance
- Cordis Corp. — 1 clearance
- Guidant Corp. — 1 clearance