| Device Type ID | 906 |
| Device Name | Injector And Syringe, Angiographic, Balloon Inflation, Reprocessed |
| Regulation Description | Angiographic Injector And Syringe. |
| 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 | 870.1650 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NKU |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 906 |
| Device | Injector And Syringe, Angiographic, Balloon Inflation, Reprocessed |
| Product Code | NKU |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Angiographic Injector And Syringe. |
| CFR Regulation Number | 870.1650 [🔎] |