510(k) K211327

Khelix Steerable Electrophysiology Catheters, Khelix Loop Fixed Electrophysiology Catheters, Khelix Fixed Loop Steerable Electrophysiology Catheters, Khelix Variable Loop Steerable Electrophysiology Catheters by CathRx, Ltd. — Product Code DRF

K211327 is an FDA 510(k) premarket notification submitted by CathRx, Ltd. for the device "Khelix Steerable Electrophysiology Catheters, Khelix Loop Fixed Electrophysiology Catheters, Khelix Fixed Loop Steerable Electrophysiology Catheters, Khelix Variable Loop Steerable Electrophysiology Catheters". The FDA issued a decision of Substantially Equivalent on February 10, 2022. The device falls under product code DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording), a Class II device regulated under 21 CFR 870.1220.