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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Electrode Recording, Or Probe, Electrode Recording
510(k) Number K262068
Device Name Khelix Magnetic Sensor Electrophysiology Catheter (SS1-*-*-MAG)
Applicant
CathRx, Ltd.
Unit 8
2-8 S. St.
Rydalmere,  AU 2116
Applicant Contact Henry Le
Correspondent
Acorn N Oakes, LLC
333 N. Dobson Rd. Suite Vo5
Chandler,  AZ  85224
Correspondent Contact Amy Oakes
Regulation Number870.1220
Classification Product Code
DRF  
Date Received06/22/2026
Decision Date 10/09/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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