PJB
- Product code
- PJB
- Device name
- Catheter Remote Control System
- Device class
- Class 2
- 21 CFR
- 21 CFR 870.5700
- Medical specialty
- Cardiovascular
- Marketing pathway
- 510(K)
- 510(k) clearances (all years, FDA)
- 4 (all years; only the last 3 years are listed here)
FDA classification 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 deflection of a steerable ablation catheter used for the treatment of cardiac arrhythmias in the right side of the heart. The device allows reversion to manual control of the steerable cardiac ablation catheter without withdrawal of the catheter and interruption of the procedure.
Official FDA classification page: PJB
Classification and pathway per current FDA publications. Data from openFDA (CC0).