Class Class II
Globe® Pulsed Field System (K250747)
Description
Globe® Pulsed Field System by Kardium, Inc., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250747
Clearance Date2025-06-25
Clearance TypeTraditional
Product CodeDQK
Regulation Number870.1425
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250747
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. Globe® Pulsed Field System (K250747) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K241828 | Affera Integrated Mapping System; Impedance Localization Pa... | Medtronic, Inc. | 2024 |
| K160084 | Swan Ganz Catheters | Edwards Lifesciences, LLC | 2016 |
Trace the full predicate network for K250747
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.