Clearance Summary
Khelix Steerable Electrophysiology Catheters, Khelix Loop Fixed Electrophysiology Catheters, Khelix Fixed Loop Steerable Electrophysiology Catheters, Khelix Variable Loop Steerable Electrophysiology Catheters received FDA 510(k) clearance under submission number K211327, sponsored by CathRx, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2022-02-10.
- Submission: K211327
- Applicant / Sponsor: CathRx, Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1220
- Decision date: 2022-02-10
Classification & Regulation
This clearance is catalogued under FDA product code DRF and 21 CFR 870.1220, within the Cardiovascular review panel as a Class II device.