Class Class II
Arctic Sun Stat Temperature Management System (K243942)
Description
Arctic Sun Stat Temperature Management System by Medivance, Inc., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243942
Clearance Date2025-04-30
Clearance TypeTraditional
Product CodeDWJ
Regulation Number870.5900
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243942
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. Arctic Sun Stat Temperature Management System (K243942) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K200225 | Arctic Sun Stat Temperature Management System | Medivance, Inc. | 2020 |
Trace the full predicate network for K243942
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.