510(k) K262068
K262068 is an FDA 510(k) premarket notification submitted by CathRx, Ltd. for the device "Khelix Magnetic Sensor Electrophysiology Catheter (SS1-*-*-MAG)". The FDA issued a decision of Substantially Equivalent on Oct 9, 2026. The device falls under product code DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording), a Class II device regulated under 21 CFR 870.1220. CathRx, Ltd. has 1 other 510(k) clearance on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 9, 2026
- Date Received
- Jun 22, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Catheter, Electrode Recording, Or Probe, Electrode Recording
- Device Class
- Class II
- Regulation Number
- 870.1220
- Review Panel
- CV
- Submission Type
- 510(k)