CathRx, Ltd. FDA Approvals

0 new drug approvals and 2 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
Khelix Magnetic Sensor Electrophysiology Catheter (SS1---MAG)510(k)Oct 9, 2026Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Oct 9, 2026
Khelix Steerable Electrophysiology Catheters, Khelix Loop Fixed Electrophysiology Catheters, Khelix Fixed Loop Steerable Electrophysiology Catheters, Khelix Variable Loop Steerable Electrophysiology Catheters510(k)Feb 10, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Feb 10, 2022