Class Class II
MAGiC Sweep™ EP Mapping Catheter (K250590)
Description
MAGiC Sweep™ EP Mapping Catheter by Stereotaxis, Inc., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250590
Clearance Date2025-07-23
Clearance TypeTraditional
Product CodeDRF
Regulation Number870.1220
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250590
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. MAGiC Sweep™ EP Mapping Catheter (K250590) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K013484 | TELSTAR MAGNETIC NAVIGATION SYSTEMS [MNS}, TELSTAR BI-PLANE... | Stereotaxis, Inc. | 2002 |
Trace the full predicate network for K250590
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.