510(k) clearance
Khelix Magnetic Sensor Electrophysiology Catheter (SS1-*-*-MAG)
- 510(k) number
- K262068
- Applicant
- CathRx, Ltd.
- Decision date
- Oct 9, 2026
- Date received
- Jun 22, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- DRF
- Device type
- Catheter, Electrode Recording, Or Probe, Electrode Recording
- Device class
- Class II
- Regulation
- 21 CFR 870.1220
- Advisory committee
- Cardiovascular
- Statement or summary
- Summary
- Third party
- N
- Location
- Rydalmere, AU