510(k) DEN140009

Clearance Details

Decision

DENG (De Novo Granted)

Decision Date

December 18, 2014

Date Received

February 18, 2014

Clearance Type

Direct

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Catheter Remote Control System

Device Class

Class II

Regulation Number

870.5700

Review Panel

CV

Submission Type

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.