Data / Medical devices / Australia / Cathrx
Cathrx: FDA-registered device maker in Rydalmere New South Wales, Australia, 2 510(k) clearances
Cathrx is registered with the FDA (registration 3014368660) in Rydalmere New South Wales, Australia. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 9, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3014368660
- Address
- Unit 8, 2-8 South St, Rydalmere New South Wales, Australia, 2116
- Owner or operator
- CathRx (10084686)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- March 22, 2022
- Registered through
- 2027
- Brand names listed
- Khelix Diagnostic Extension Cable, Khelix Fixed Electrophysiology Catheter, Khelix Fixed Loop Steerable Electrophysiology Catheters, Khelix Loop Electrophysiology Catheter, Khelix Magnetic Sensor Electrophysiology Catheter, Khelix Steerable Electrophysiology Catheter, Khelix Variable Loop Steerable Electrophysiology Catheters
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cable, Electrode | IKD | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Catheter, Electrode Recording, Or Probe, Electrode Recording | DRF | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 9, 2026 | K262068 | Khelix Magnetic Sensor Electrophysiology Catheter (SS1-*-*-MAG) | DRF | Substantially Equivalent | CathRx, Ltd. | accessdata.fda.gov |
| February 10, 2022 | K211327 | Khelix Steerable Electrophysiology Catheters, Khelix Loop Fixed Electrophysiology Catheters, Khelix Fixed Loop Steerable Electrophysiology Catheters, Khelix Variable Loop Steerable Electrophysiology Catheters | DRF | Substantially Equivalent | CathRx, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter, Electrode Recording, Or Probe, Electrode Recording
- All makers of Cable, Electrode
Updated October 9, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.