Class Class II
Gunther Tulip Vena Cava Filter Retrieval Set (K222254)
Description
Gunther Tulip Vena Cava Filter Retrieval Set by Cook Incorporated, an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK222254
Clearance Date2023-05-16
Clearance TypeTraditional
Product CodeMMX
Regulation Number870.5150
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K222254
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. Gunther Tulip Vena Cava Filter Retrieval Set (K222254) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K181757 | Günther Tulip® Vena Cava Filter Retrieval Set | Cook Incorporated | 2018 |
Trace the full predicate network for K222254
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.