Class Class II
Embosphere Microspheres (K250971)
Description
Embosphere Microspheres by Biosphere Medical, S.A., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250971
Clearance Date2025-05-16
Clearance TypeTraditional
Product CodeKRD
Regulation Number870.3300
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250971
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. Embosphere Microspheres (K250971) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K181300 | Embosphere Microspheres | Biosphere Medical, S.A. | 2018 |
Trace the full predicate network for K250971
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.