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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 the device name listed in this FDA 510(k) record. The listed applicant is Stereotaxis, Inc.. It received FDA 510(k) clearance on 2025-07-23 under 510(k) 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. The listed applicant is Stereotaxis, Inc.. The 510(k) number is K250590.

When did MAGiC Sweep™ EP Mapping Catheter receive FDA 510(k) clearance?

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

Who is the listed applicant for MAGiC Sweep™ EP Mapping Catheter?

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

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

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

Other records listing Stereotaxis, Inc. 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.

PMA P240014Cardiac ablation percutaneous catheterK253473SynchronyK251792Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS)K193147Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive SystemK192775Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and CardiodriK183027Steerable catheter control system

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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.K250310VIKING™ Fixed Curve Diagnostic CatheterBoston Scientific CorporationPMA P990025CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDINGBiosense Webster, Inc.K240366EP•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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