DeviceClearance

Product code PJB— Cardiovascular

AMIGO REMOTE CATHETER SYSTEM

Classification name
Catheter Remote Control System
Device class
Class 2
Regulation
21 CFR 870.5700
Advisory panel
Cardiovascular
Total cleared
4
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code PJB under 21 CFR 870.5700, via openFDA

Market context for product code PJB

FDA has cleared 4 devices under product code PJB between 2014 and 2020, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PJB

Recent clearances under product code PJB

Data sourced from openFDA. This site is unofficial and independent of the FDA.