Class Class II
Elfor-L (K243852)
Description
Elfor-L by Elfi-Tech , Ltd., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243852
Clearance Date2025-04-14
Clearance TypeTraditional
Product CodeDPW
Regulation Number870.2100
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243852
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. Elfor-L (K243852) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K152930 | PeriFlux6000 | Perimed AB | 2016 |
Trace the full predicate network for K243852
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.