510(k) K211327 ยท DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Khelix Steerable Electrophysiology Catheters, Khelix Loop Fixed Electrophysiology Catheters, Khelix Fixed Loop Steerable Electrophysiology Catheters, Khelix Variable Loop Steerable Electrophysiology Catheters
| Applicant | CathRx, Ltd., Rydalmere, AU |
| Decision | Substantially Equivalent, Feb 10, 2022 |
| Received | May 3, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211327
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.