Cleared Traditional

MAGiC Sweep? EP Mapping Catheter

K250590 · Stereotaxis, Inc. · Cardiovascular
Jul 2025
Decision
146d
Days
Class 2
Risk

About This 510(k) Submission

K250590 is an FDA 510(k) clearance for the MAGiC Sweep? EP Mapping Catheter, a Catheter, Electrode Recording, Or Probe, Electrode Recording (Class II — Special Controls, product code DRF), submitted by Stereotaxis, Inc. (St. Louis, US). The FDA issued a Cleared decision on July 23, 2025, 146 days after receiving the submission on February 27, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1220.

Submission Details

510(k) Number K250590 FDA.gov
FDA Decision Cleared SESE
Date Received February 27, 2025
Decision Date July 23, 2025
Days to Decision 146 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DRF — Catheter, Electrode Recording, Or Probe, Electrode Recording
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1220

Similar Devices — DRF Catheter, Electrode Recording, Or Probe, Electrode Recording

All 184
Vision-MR? Diagnostic Catheter
K252794 · Imricor Medical Systems, Inc. · Jan 2026
VIKING? Fixed Curve Diagnostic Catheter
K250310 · Boston Scientific Corporation · Jun 2025
EP?XT? Unidirectional Steerable Diagnostic Catheter; Dynamic Tip? Unidirectional Steerable Diagnostic Catheter; Dynamic XT? Unidirectional Steerable Diagnostic Catheter
K240366 · Boston Scientific Corporation · Nov 2024
Nordica PV Cryo Mapping Catheter
K233900 · Synaptic Medical Corporation · Sep 2024
Cosine-10TM Diagnostic Catheter
K233397 · Medtronic, Inc. · Dec 2023
Polaris X? Unidirectional Steerable Diagnostic Catheter
K233207 · Boston Scientific Corporation · Oct 2023