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FDA 510(k)

Khelix Magnetic Sensor Electrophysiology Catheter (SS1-*-*-MAG)

K-Number: K262068 · 2026-10-09

ApplicantCathRx, Ltd.
Decision Date2026-10-09
Product CodeDRF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Khelix Magnetic Sensor Electrophysiology Catheter (SS1-*-*-MAG) is the device name listed in this FDA 510(k) record. The listed applicant is CathRx, Ltd.. It received FDA 510(k) clearance on 2026-10-09 under 510(k) number K262068. The device is classified under product code DRF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Khelix Magnetic Sensor Electrophysiology Catheter (SS1-*-*-MAG)?

Khelix Magnetic Sensor Electrophysiology Catheter (SS1-*-*-MAG) is a medical device that received FDA 510(k) clearance on 2026-10-09. The listed applicant is CathRx, Ltd.. The 510(k) number is K262068.

When did Khelix Magnetic Sensor Electrophysiology Catheter (SS1-*-*-MAG) receive FDA 510(k) clearance?

Khelix Magnetic Sensor Electrophysiology Catheter (SS1-*-*-MAG) received FDA 510(k) clearance on 2026-10-09, under 510(k) number K262068.

Who is the listed applicant for Khelix Magnetic Sensor Electrophysiology Catheter (SS1-*-*-MAG)?

The FDA 510(k) record lists CathRx, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Khelix Magnetic Sensor Electrophysiology Catheter (SS1-*-*-MAG)?

The FDA product code for Khelix Magnetic Sensor Electrophysiology Catheter (SS1-*-*-MAG) is DRF.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT04745156A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade GliomasNOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED

Other records listing CathRx, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K211327Khelix Steerable Electrophysiology Catheters, Khelix Loop Fixed Electrophysiology Catheters, Khelix Fixed Loop Steerable Electrophysiology Catheters, Khelix Variable Loop Steerable Electrophysiology Catheters

Related Devices (Code: DRF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252794Vision-MR™ Diagnostic CatheterImricor Medical Systems, Inc.K250590MAGiC Sweep™ EP Mapping CatheterStereotaxis, Inc.K250310VIKING™ Fixed Curve Diagnostic CatheterBoston Scientific CorporationK240366EP•XT™ Unidirectional Steerable Diagnostic Catheter; Dynamic Tip™ Unidirectional Steerable Diagnostic Catheter; Dynamic XT™ Unidirectional Steerable Diagnostic CatheterBoston Scientific CorporationK233900Nordica PV Cryo Mapping CatheterSynaptic Medical CorporationK233397Cosine-10TM Diagnostic CatheterMedtronic, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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