Medical Device Manufacturer · AU , Rydalmere

CathRx, Ltd. - FDA 510(k) Cleared Devices

1 submissions · 1 cleared · Since 2022

Recent clearances: Khelix Steerable Electrophysiology Catheters, Khelix Loop Fixed Electrophysiology Catheters, Khelix Fixed Loop Steerable Electrophysiology Catheters, Khelix Variable Loop Steerable Electrophysiology Catheters

1

Total

1

Cleared

0

Denied

FDA 510(k) Regulatory Record - CathRx, Ltd. Cardiovascular ✕

1 devices

1-1 of 1

Cleared Feb 10, 2022

Khelix Steerable Electrophysiology Catheters, Khelix Loop Fixed...

Cardiovascular · 283d

Data Source

Sourced from the FDA 510(k) public files . 175,450 total devices indexed.

Last updated: May 21, 2026