Class Class II
Protrieve Sheath (K230331)
Description
Protrieve Sheath by Inari Medical, Inc., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK230331
Clearance Date2023-03-07
Clearance TypeSpecial
Product CodeQEW
Regulation Number870.5150
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230331
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. Protrieve Sheath (K230331) cites 2 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K220415 | Protrieve Sheath | Inari Medical, Inc. | 2022 |
| K212392 | Intri24 Sheath | Inari Medical, Inc. | 2022 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K233815 | ClotTriever Sheath | Inari Medical, Inc. | 2023 |
Trace the full predicate network for K230331
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.