Data / Medical devices / United States / Inari Medical, Inc.
Inari Medical, Inc.: FDA-registered device maker in Irvine, CA, United States, 22 510(k) clearances
Inari Medical, Inc. is registered with the FDA (registration 3020347218) in Irvine, CA, United States. It lists 6 device types. The FDA files 22 510(k) clearances under its listings, the newest dated October 29, 2025. 2 recall events name it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3020347218
- Address
- 6001 Oak Canyon, Suite 100, Irvine, CA, United States, 92618
- Owner or operator
- STRYKER CORP. (1811755)
- Roles
- Manufacturer
- First device listed
- February 26, 1997
- Registered through
- 2026
- Brand names listed
- Artix AX, Artix BG, Artix MT, Artix Thin-Walled Thrombectomy Sheath, ClotTriever BOLD Catheter, ClotTriever Bold Catheter, 16mm, ClotTriever Catheter, ClotTriever Catheter, 16mm and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Apparatus, Autotransfusion | CAC | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Continuous Flush | KRA | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Percutaneous | DQY | 2 | Manufacturer | accessdata.fda.gov |
| Introducer, Catheter | DYB | 2 | Manufacturer | accessdata.fda.gov |
| Peripheral Mechanical Thrombectomy With Aspiration | QEW | 2 | Manufacturer | accessdata.fda.gov |
| Retention Device, Suture | KGS | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 29, 2025 | K253323 | Protrieve Sheath | QEW | Substantially Equivalent | Inari Medical | accessdata.fda.gov |
| May 12, 2025 | K250421 | InThrill Thrombectomy System | QEW | Substantially Equivalent | Inari Medical, Inc. | accessdata.fda.gov |
| March 13, 2025 | K250088 | FlowTriever2 Catheter | QEW | Substantially Equivalent | Inari Medical, Inc. | accessdata.fda.gov |
| October 15, 2024 | K241894 | Artix MT; Artix Thin-Walled Thrombectomy Sheath | QEW | Substantially Equivalent | Inari Medical, Inc. | accessdata.fda.gov |
| September 27, 2024 | K242557 | ClotTriever XL Catheter (41-102) | QEW | Substantially Equivalent | Inari Medical, Inc. | accessdata.fda.gov |
| February 9, 2024 | K234034 | VenaCore Thrombectomy Catheter (46-101) | QEW | Substantially Equivalent | Inari Medical, Inc. | accessdata.fda.gov |
| December 18, 2023 | K233815 | ClotTriever Sheath | QEW | Substantially Equivalent | Inari Medical, Inc. | accessdata.fda.gov |
| December 12, 2023 | K233646 | Intri24 Introducer Sheath (52-101) | DYB | Substantially Equivalent | Inari Medical, Inc. | accessdata.fda.gov |
| September 27, 2023 | K231108 | Talon Transseptal Sheath | DYB | Substantially Equivalent | Inari Medical, Inc. | accessdata.fda.gov |
| July 21, 2023 | K231848 | Triever20 Curve (21-201) | QEW | Substantially Equivalent | Inari Medical, Inc. | accessdata.fda.gov |
| July 14, 2023 | K231782 | FlowSaver Blood Return System (80-101) | CAC | Substantially Equivalent | Inari Medical, Inc. | accessdata.fda.gov |
| May 2, 2023 | K230912 | Artix BG | QEW | Substantially Equivalent | Inari Medical | accessdata.fda.gov |
| April 18, 2023 | K230494 | ClotTriever BOLD Catheter | QEW | Substantially Equivalent | Inari Medical, Inc. | accessdata.fda.gov |
| March 23, 2023 | K223419 | Triever16 Curve | QEW | Substantially Equivalent | Inari Medical | accessdata.fda.gov |
| March 14, 2023 | K223609 | RevCore Thrombectomy Catheter. | QEW | Substantially Equivalent | Inari Medical, Inc. | accessdata.fda.gov |
| March 2, 2023 | K223436 | Artix AX | QEW | Substantially Equivalent | Inari Medical | accessdata.fda.gov |
| February 17, 2023 | K221483 | FlowSaver Blood Return System | CAC | Substantially Equivalent | Inari Medical, Inc. | accessdata.fda.gov |
| February 6, 2023 | K221531 | ClotTriever Thrombectomy System | QEW | Substantially Equivalent | Inari Medical, Inc. | accessdata.fda.gov |
| May 23, 2022 | K213402 | Triever24, Triever20 | QEW | Substantially Equivalent | Inari Medical | accessdata.fda.gov |
| May 12, 2021 | K210689 | ClotTriever Thrombectomy System | QEW | Substantially Equivalent | Inari Medical, Inc. | accessdata.fda.gov |
| April 30, 2021 | K211013 | FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16, Triever 20, Triever 20 Curve, Triever 24 | QEW | Substantially Equivalent | Inari Medical, Inc. | accessdata.fda.gov |
| February 23, 2021 | K210190 | ClotTriever Thrombectomy System | QEW | Substantially Equivalent | Irani Medical, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 8, 2025 | 96682 | Class II | Ongoing | Artix MT Thrombectomy Device, REF: 32-102 | Thrombectomy device specifies vessel range of 2.5-6 mm on the pouch, carton, and Instructions for Use rather than the correct vessel range of 3-6 mm, which could incrementally increase the radial force on the artery, which has the potential of vascular complications. | accessdata.fda.gov |
| July 19, 2024 | 95069 | Class I | Ongoing | ClotTriever XL Catheter, 30 mm, REF: 41-102, used with Instructions for Use ClotTriever XL Catheter ClotTriever Thrombectomy System, Reference: IU-01011 | Thrombectomy system catheter instructions for use updated to reduce adverse events due to the following circumstances: 1) Fibrous, firmly adherent, calcified material, or suspected tumor thrombus overloading catheter bag 2) Catheter pulled through internal jugular vein access site or not pulled away from heart; may lead to device entrapment, pulmonary emboli | accessdata.fda.gov |
Compare with other makers
- All makers of Peripheral Mechanical Thrombectomy With Aspiration
- All makers of Catheter, Continuous Flush
- All makers of Introducer, Catheter
- All makers of Catheter, Percutaneous
- All makers of Apparatus, Autotransfusion
- All makers of Retention Device, Suture
Updated October 29, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.