Class Class II
Artix™ MT; Artix™ Thin-Walled Thrombectomy Sheath (K241894)
Description
Artix™ MT; Artix™ Thin-Walled Thrombectomy Sheath by Inari Medical, Inc., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241894
Clearance Date2024-10-15
Clearance TypeTraditional
Product CodeQEW
Regulation Number870.5150
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241894
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. Artix™ MT; Artix™ Thin-Walled Thrombectomy Sheath (K241894) cites 5 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K231022 | Pounce Thrombectomy System | Surmodics,Inc. | 2023 |
| K230912 | Artix BG | Inari Medical | 2023 |
| K220600 | Artix Thrombectomy Device | Inari Medical | 2022 |
| K203476 | CAPERE Thrombectomy System | Vascular Medcure, Inc. | 2020 |
| K171493 | MegaVac Mechanical Thrombectomy System | Capture Vascular, Inc. | 2017 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K250421 | InThrill Thrombectomy System | Inari Medical, Inc. | 2025 |
Trace the full predicate network for K241894
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.