PJB · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.5700
Classification
FDA Product Code
PJB
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 870.5700
Review panel
CV
Medical specialty
Cardiovascular
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.