CathRx, Ltd. · Class II · Cleared Feb 10, 2022
| K-number | K211327 |
| Device name | Khelix Steerable Electrophysiology Catheters, Khelix Loop Fixed Electrophysiology Catheters, Khelix Fixed Loop Steerable Electrophysiology Catheters, Khelix Variable Loop Steerable Electrophysiology Catheters |
| Applicant | CathRx, Ltd. |
| Product code | DRF |
| Device class | Class II |
| Decision date | Feb 10, 2022 |
| Decision | Substantially Equivalent |
| Regulation | 870.1220 |
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