Company · US
Inari Medical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2015 to 2026. Name variants (Inc, Corp, punctuation) are merged.
58510(k) clearances (3 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 18, 2026 | K253419 | Triever Duo Catheter Inari Medical, Inc. | QEW |
| Aug 21, 2026 | K262538 | Artix MT;Artix Thin-Walled Sheath Inari Medical, Inc. | QEW |
| Dec 17, 2025 | K252508 | Intri26 Introducer Sheath Inari Medical, Inc. | DYB |
| Oct 29, 2025 | K253323 | Protrieve Sheath Inari Medical | QEW |
| May 12, 2025 | K250421 | InThrill Thrombectomy System Inari Medical, Inc. | QEW |
| Mar 13, 2025 | K250088 | FlowTriever2 Catheter Inari Medical, Inc. | QEW |
| Oct 15, 2024 | K241894 | Artix MT; Artix Thin-Walled Thrombectomy Sheath Inari Medical, Inc. | QEW |
| Sep 27, 2024 | K242557 | ClotTriever XL Catheter (41-102) Inari Medical, Inc. | QEW |
| Mar 26, 2024 | K233069 | Removal System Large Bore 60 cc Syringe Inari Medical, Inc. | PUR |
| Feb 9, 2024 | K234034 | VenaCore Thrombectomy Catheter (46-101) Inari Medical, Inc. | QEW |
| Dec 18, 2023 | K233815 | ClotTriever Sheath Inari Medical, Inc. | QEW |
| Dec 12, 2023 | K233646 | Intri24 Introducer Sheath (52-101) Inari Medical, Inc. | DYB |
| Sep 27, 2023 | K231108 | Talon Transseptal Sheath Inari Medical, Inc. | DYB |
| Jul 21, 2023 | K231848 | Triever20 Curve (21-201) Inari Medical, Inc. | QEW |
| Jul 14, 2023 | K231782 | FlowSaver Blood Return System (80-101) Inari Medical, Inc. | CAC |
| May 2, 2023 | K230912 | Artix BG Inari Medical | QEW |
| Apr 27, 2023 | K223210 | ClotTriever XL Catheter Inari Medical, Inc. | QEW |
| Apr 18, 2023 | K230494 | ClotTriever BOLD Catheter Inari Medical, Inc. | QEW |
| Mar 23, 2023 | K223419 | Triever16 Curve Inari Medical | QEW |
| Mar 17, 2023 | K223613 | InThrill Thrombectomy System Inari Medical, Inc. | QEW |
| Mar 14, 2023 | K223609 | RevCore Thrombectomy Catheter. Inari Medical, Inc. | QEW |
| Mar 7, 2023 | K230331 | Protrieve Sheath Inari Medical, Inc. | QEW |
| Mar 2, 2023 | K223436 | Artix AX Inari Medical | QEW |
| Feb 17, 2023 | K221483 | FlowSaver Blood Return System Inari Medical, Inc. | CAC |
| Feb 6, 2023 | K221531 | ClotTriever Thrombectomy System Inari Medical, Inc. | QEW |
| Jan 11, 2023 | K223000 | Artix BG Inari Medical | QEW |
| Aug 4, 2022 | K220887 | Mini-ClotTriever Thrombectomy System Inari Medical | QEW |
| Jul 12, 2022 | K220415 | Protrieve Sheath Inari Medical, Inc. | QEW |
| Jul 11, 2022 | K221846 | Artix Ballon Guiding Sheath Inari Medical | DQY |
| May 23, 2022 | K213402 | Triever24, Triever20 Inari Medical | QEW |
| Apr 1, 2022 | K212392 | Intri24 Sheath Inari Medical, Inc. | DYB |
| Mar 25, 2022 | K220600 | Artix Thrombectomy Device Inari Medical | QEW |
| Oct 18, 2021 | K212632 | ClotTriever Thrombectomy System Inari Medical, Inc. | QEW |
| Jul 22, 2021 | K210176 | FlowSaver Blood Filter Inari Medical | CAC |
| May 12, 2021 | K210689 | ClotTriever Thrombectomy System Inari Medical, Inc. | QEW |
| Apr 30, 2021 | K211013 | FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16, Triever 20, Triever 20 Curve, Triever 24 Inari Medical, Inc. | QEW |
| Feb 24, 2021 | K210195 | Triever Catheters Inari Medical | QEW |
| Dec 18, 2020 | K202345 | FlowTriever Retrieval/Aspiration System Inari Medical | QEW |
| Dec 10, 2020 | K203333 | Triever20 Curve Catheter Inari Medical, Inc. | QEW |
| Dec 4, 2020 | K201541 | FlowTriever Retrieval/Aspiration System Inari Medical | QEW |
| Sep 9, 2020 | K193462 | ClotTriever Thrombectomy System Inari Medical | QEW |
| Sep 20, 2019 | K192332 | ClotTriever Thrombectormy System, ClotTriever Catheter, ClotTriever Sheath Inari Medical | QEW |
| Sep 5, 2019 | K191710 | FlowTriever Retrieval/Aspiration System Inari Medical | QEW |
| Aug 29, 2019 | K192036 | ClotTriever Thrombectomy System Inari Medical | QEW |
| Jun 17, 2019 | K191368 | FlowTriever Retrieval/Aspiration System Inari Medical | QEW |
| Dec 17, 2018 | K183198 | FlowTriever Retrieval/Aspiration System Inari Medical | QEW |
| Oct 15, 2018 | K182233 | FlowTriever Retrieval/Aspiration System Inari Medical | QEW |
| Oct 10, 2018 | K182531 | ClotTriever Thrombectomy System Inari Medical | QEW |
| Jul 27, 2018 | K181694 | FlowTriever Retrieval/Aspiration System Inari Medical | QEW |
| Jun 17, 2018 | K181325 | FlowTriever Retrieval/Aspiration System Inari Medical, Inc. | QEW |
Newest 50 of 58.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 23, 2020 | INARI MEDICAL Triever20 Aspiration Guide Catheter a component of FlowTriever Retrieval/ Aspiration System, UDI: 00850291007079 Terminated |
DXE | K182233 |