# K250590: MAGiC Sweep™ EP Mapping Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Stereotaxis, Inc.
- Decided: Jul 23, 2025 after 146 days
- Product code: DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording)
- Device class: 2
- Regulation: 21 CFR 870.1220
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K900765 (1990). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013484: Telstar Magnetic Navigation Systems [MNS}, Telstar BI-Plane Digital Imaging System, Niobe Electrophysiology Mapping Cath, Stereotaxis, Inc. (2002) Summary page 6.

## Indications for use
The MAGiC Sweep™ EP Mapping Catheter is intended for intracardiac electrophysiological recording and/or stimulation for pacing in the heart.

Source page: https://510kreport.com/device/K250590
Methodology: https://510kreport.com/methodology