# Catheter Remote Control System
> **Product code: 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.

## Market data
- **Cleared 510(k) submissions:** 4
- **Registered establishments:** 1
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=PJB)
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