Definition: Percutaneous Transluminal Angioplasty Of Peripheral Vasculature Exclusive Of Coronary Arteries
| Device Type ID | 922 |
| Device Name | Catheter, Angioplasty, Peripheral, Transluminal, Dual-balloon |
| Physical State | Comprised Of A Catheter Body With Two Concentric Distal Inflatable Balloons. |
| Technical Method | Used Independently For Dilation Or Dilatation Of Diseased Peripheral Vasculature To Restore Blood Flow |
| Target Area | Peripheral Vasculature Exclusive Of Coronary Arteries. |
| Regulation Description | Percutaneous Catheter. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Interventional Cardiology Devices Branch (ICDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.1250 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NVM |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 922 |
| Device | Catheter, Angioplasty, Peripheral, Transluminal, Dual-balloon |
| Product Code | NVM |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Percutaneous Catheter. |
| CFR Regulation Number | 870.1250 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
NUMED, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |