| Device Type ID | 3630 |
| Device Name | System, Catheter Or Guidewire, Steerable (magnetic) |
| Regulation Description | Steerable Catheter Control System. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Neurology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Neurointerventional Devices Branch (NIDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.1290 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NDQ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3630 |
| Device | System, Catheter Or Guidewire, Steerable (magnetic) |
| Product Code | NDQ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Steerable Catheter Control System. |
| CFR Regulation Number | 870.1290 [🔎] |