Class Class II
Excipio LV Thrombectomy Device (K223897)
Description
Excipio LV Thrombectomy Device by Contego Medical, Inc., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223897
Clearance Date2023-02-17
Clearance TypeTraditional
Product CodeQEW
Regulation Number870.5150
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223897
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. Excipio LV Thrombectomy Device (K223897) cites 3 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K221204 | Excipio SV Thrombectomy Device | Contego Medical, Inc. | 2022 |
| K213402 | Triever24, Triever20 | Inari Medical | 2022 |
| K203476 | CAPERE Thrombectomy System | Vascular Medcure, Inc. | 2020 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K251485 | Excipio LV Prime Thrombectomy Device | Contego Medical, Inc. | 2025 |
Trace the full predicate network for K223897
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.