Khelix Magnetic Sensor Electrophysiology Catheter (SS1---MAG)— 510(k) K262068

Name: FDA 510(k) clearance K262068
Creator: U.S. Food and Drug Administration
Published: 2026-10-09

Substantially Equivalent

CathRx, Ltd.

FDA 510(k) clearance K262068 for Khelix Magnetic Sensor Electrophysiology Catheter (SS1-*-*-MAG), Substantially Equivalent on 2026-10-09. Applicant: CathRx, Ltd.. Device class: 2.

Summary

CathRx's Khelix Magnetic Sensor Electrophysiology Catheter is filed under DRF, electrode recording catheters and probes. The model string SS1---MAG uses wildcards, so the clearance covers a family of configurations. The record doesn't say what the magnetic sensor works with.

Class II, 21 CFR 870.1220. The Cardiovascular panel reviewed it as a Traditional 510(k).

CathRx filed from Rydalmere, Australia. Review took 109 days (June 22 to October 9, 2026).

Clearance details

Applicant: CathRx, Ltd.
Product code: Product code DRF
Device class: Class 2
Regulation: 21 CFR 870.1220
Advisory panel: Cardiovascular
Date received: 2026-06-22
Decision date: 2026-10-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rydalmere, AU

Download summary PDF View on FDA.gov ↗

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K211327 — Khelix Steerable Electrophysiology Catheters, Khelix Loop Fixed Electrophysiology Catheters, Khelix Fixed Loop Steerable Electrophysiology Catheters, Khelix Variable Loop Steerable Electrophysiology Catheters2022-02-10

Adverse events under product code DRF

product code DRF

Death: 127
Injury: 1,676
Malfunction: 2,003
Other: 1
Total: 3,807

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.