The following data is part of a premarket notification filed by Cathrxltd with the FDA for Khelix Steerable Electrophysiology Catheters, Khelix Loop Fixed Electrophysiology Catheters, Khelix Fixed Loop Steerable Electrophysiology Catheters, Khelix Variable Loop Steerable Electrophysiology Catheters.
| Device ID | K211327 |
| 510k 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 |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | CathRxLtd Unit 8, 2-8 South St Rydalmere, AU 2116 |
| Contact | Lucy Huang |
| Correspondent | Amy Oakes Acom N Oakes LLC 333 N. Dobson Rd. Suite 5 Chandler, AZ 85224 |
| Product Code | DRF |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-03 |
| Decision Date | 2022-02-10 |