Class Class II
Artix BG (K230912)
Description
Artix BG by Inari Medical, an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK230912
Clearance Date2023-05-02
Clearance TypeSpecial
Product CodeQEW
Regulation Number870.5150
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230912
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 BG (K230912) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K223000 | Artix BG | Inari Medical | 2023 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K241894 | Artix™ MT; Artix™ Thin-Walled Thrombectomy Sheath | Inari Medical, Inc. | 2024 |
Trace the full predicate network for K230912
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.