Class Class II
RAP Femoral Venous Cannulae (K250283)
Description
RAP Femoral Venous Cannulae by LivaNova USA, Inc., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250283
Clearance Date2025-07-10
Clearance TypeSpecial
Product CodeDWF
Regulation Number870.4210
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250283
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. RAP Femoral Venous Cannulae (K250283) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K052081 | REMOTE ACCESS PERFUSION (RAP) FEMORAL VENOUS CANNULA | Estech, Inc. | 2005 |
Trace the full predicate network for K250283
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.