Definition: A Steerable Cardiac Ablation Catheter Remote Control System Is A Device That Is External To The Body And Interacts With The Manual Handle Of A Steerable Cardiac Ablation Catheter To Remotely Control The Advancement, Retraction, Rotation, And Deflecti
| Device Type ID | 966 |
| Device Name | Catheter Remote Control System |
| Physical State | Consists Of Non-sterile, Reusable Components Including The Remote Catheter System (sled, Track, And Turret), A Hard-wired Remote Control, A Bridge Support With Rail And Frame, As Well As A Sterile, Single Use Docking Station And Spreader To Interface |
| Technical Method | Uses Electronic Stepper Motors To Operate The Manual Handle Of A Steerable Cardiac Ablation Catheter To Remotely Control Its Advancement, Retraction, Rotation, And Deflection. The System Does Not Use Software Or Decision Logic To Control The Catheter |
| Target Area | Right Atrium |
| Regulation Description | Steerable Cardiac Ablation Catheter Remote Control System. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Cardiac Electrophysiology Devices Branch (CEDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.5700 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PJB |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 966 |
| Device | Catheter Remote Control System |
| Product Code | PJB |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Steerable Cardiac Ablation Catheter Remote Control System. |
| CFR Regulation Number | 870.5700 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
CATHETER ROBOTICS INC | ||
GRANTED | 1 | |