PJB · Class II · 21 CFR 870.5700

FDA Product Code PJB: Catheter Remote Control System

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.

4
Total
3
Cleared
189d
Avg days
2014
Since

FDA 510(k) Cleared Catheter Remote Control System Devices (Product Code PJB)

4 devices
1–4 of 4
No devices found for this product code.

About Product Code PJB - Regulatory Context