Khelix Steerable Electrophysiology Catheters, Khelix Loop Fixed Electrophysiology Catheters, Khelix Fixed Loop Steerable Electrophysiology Catheters, Khelix Variable Loop Steerable Electrophysiology Catheters— 510(k) K211327

Substantially Equivalent

CathRx, Ltd.

FDA 510(k) clearance K211327 for Khelix Steerable Electrophysiology Catheters, Khelix Loop Fixed Electrophysiology Catheters, Khelix Fixed Loop Steerable Electrophysiology Catheters, Khelix Variable Loop Steerable Electrophysiology Catheters, Substantially Equivalent on 2022-02-10. Applicant: CathRx, Ltd..

Clearance details

Applicant: CathRx, Ltd.
Product code: Code DRF
Advisory panel: Cardiovascular
Date received: 2021-05-03
Decision date: 2022-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rydalmere, AU

Download summary PDF View on FDA.gov ↗

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.