K250590
- 510(k) number
- K250590
- Device name
- MAGiC Sweep EP Mapping Catheter
- Applicant
- Stereotaxis, Inc. MO · US
- Product code
- DRF — Catheter, Electrode Recording, Or Probe, Electrode R
- Decision date
- 2025-07-23
- Date received
- 2025-02-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K250590.pdf
Official FDA record: K250590
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.