Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014368660

FEI Number

3014368660

Entity Name

CATHRX

City/State/Country

Rydalmere New South Wales, AU

Establishment Address

Unit 8, 2-8 South St, Rydalmere New South Wales 2116, AU

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

CathRx (Owner Number: 10084686)

Owner / Operator Contact Address

Unit 8, 2-8 South St, Rydalmere, AU-NSW 2116, AU

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K211327

PMA Number

N/A

All Registered Proprietary Names

Khelix Fixed Electrophysiology Catheter Khelix Variable Loop Steerable Electrophysiology Catheters Khelix Steerable Electrophysiology Catheter Khelix Fixed Loop Steerable Electrophysiology Catheters Khelix Loop Electrophysiology Catheter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2022-03-22

Official Correspondent

Jianhe Chen

US Agent Details

Amy Oakes Business: Acorn N Oakes LLC Email: acornnoakes@cox.net Phone: (480) 3042165

Related Public Records

Same Entity

CathRx

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K881966	C.R. Bard, Inc.	ELECTROPHYSIOLOGY ELECTRODE CATH. W/SILVER/SILVER	1988-10-04
K192037	ABBOTT MEDICAL	Advisor VL Circular Mapping Catheter, Sensor Enabled	2019-09-17

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014368660. Last updated year: 2026. Please use registration number 3014368660 when referencing this establishment in official correspondence.