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FDA 510(k)

MAGiC Sweep™ EP Mapping Catheter

K-Number: K250590 · 2025-07-23

ApplicantStereotaxis, Inc.
Decision Date2025-07-23
Product CodeDRF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MAGiC Sweep™ EP Mapping Catheter is a medical device manufactured by Stereotaxis, Inc.. It received FDA 510(k) clearance on 2025-07-23 under approval number K250590. 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 MAGiC Sweep™ EP Mapping Catheter?

MAGiC Sweep™ EP Mapping Catheter is a medical device that received FDA 510(k) clearance on 2025-07-23. It is manufactured by Stereotaxis, Inc.. The 510(k) number is K250590.

When was MAGiC Sweep™ EP Mapping Catheter approved by the FDA?

MAGiC Sweep™ EP Mapping Catheter received FDA 510(k) clearance on 2025-07-23, under approval number K250590.

What company makes MAGiC Sweep™ EP Mapping Catheter?

MAGiC Sweep™ EP Mapping Catheter is manufactured by Stereotaxis, Inc..

What is the FDA product code for MAGiC Sweep™ EP Mapping Catheter?

The FDA product code for MAGiC Sweep™ EP Mapping Catheter is DRF.

Related Clinical Trials

NCT01254474 Evaluation of Depolarization and Repolarisation Activity During Cardiac Arrhythmia Using a Novel Monophasic Action Potential Catheter COMPLETED NCT06510556 Feasibility Study of the FARAFLEX Mapping and PFA System RECRUITING NCT03053141 RHythmia mAPping and Signal acquisitiOn for Data analYsis (RHAPSODY) RECRUITING NCT06968026 Right Prefrontal Autonomic Mapping in Recurrent Pregnancy Loss With Comorbid Anxiety RECRUITING NCT05225935 Computed Tomography-Guided Catheter Ablation for Ventricular Tachycardia COMPLETED NCT07308847 Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360) RECRUITING

Other Devices by Stereotaxis, Inc.

K192775Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri K183027Steerable catheter control system K193147Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System K251792Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS) K253473Synchrony PMA P240014Cardiac ablation percutaneous catheter

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Related Devices (Code: DRF)

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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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