# K211327: Khelix Steerable Electrophysiology Catheters, Khelix Loop Fixed Electrophysiology Catheters, Khelix Fixed Loop Steerable Electrophysiology Catheters, Khelix Variable Loop Steerable Electrophysiology Catheters

- Pathway: 510(k) (Traditional)
- Applicant: CathRx, Ltd.
- Decided: Feb 10, 2022 after 283 days
- Product code: DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording)
- Device class: 2
- Regulation: 21 CFR 870.1220
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K002333 (2000). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113213: Lasso 2515 Nav Eco Variable Catheter Lasso Nav Eco Catheter Continued From Line 2, Biosense Webster, Inc. (2011) Summary page 4.

## Indications for use
The Khelix Diagnostic Electrophysiology Catheters are indicated for the electrical recording or stimulation of endocardial structures. The loop versions of the catheters are intended for obtaining and recording electrograms from the atrial region of the heart.

Source page: https://510kreport.com/device/K211327
Methodology: https://510kreport.com/methodology