Data / Medical devices / Costa Rica / Inari Medical, Costa Rica S.R.L.
Inari Medical, Costa Rica S.R.L.: FDA-registered device maker in Grecia Alajuela, Costa Rica, 3 510(k) clearances
Inari Medical, Costa Rica S.R.L. is registered with the FDA (registration 3040801290) in Grecia Alajuela, Costa Rica. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated July 21, 2023. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3040801290
- Address
- Evolution Free Zone, Building 02 Tacares, Grecia Alajuela, Costa Rica, 20305
- Owner or operator
- STRYKER CORP. (1811755)
- Roles
- Manufacturer
- First device listed
- March 10, 2025
- Registered through
- 2026
- Brand names listed
- FlowTriever Catheter, 11-14 mm, FlowTriever Catheter, 15-18 mm, FlowTriever Catheter, 19-25 mm, FlowTriever Catheter, 6-10 mm, FlowTriever Retrieval/ Aspiration System, FlowTriever Retrieval/Aspiration System, Large Bore Syringe, 60 cc, Large Bore Syringe, 60 cc, 3-Pack and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Continuous Flush | KRA | 2 | Manufacturer | accessdata.fda.gov |
| Peripheral Mechanical Thrombectomy With Aspiration | QEW | 2 | 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 |
|---|---|---|---|---|---|---|
| July 21, 2023 | K231848 | Triever20 Curve (21-201) | QEW | Substantially Equivalent | Inari Medical, Inc. | accessdata.fda.gov |
| May 23, 2022 | K213402 | Triever24, Triever20 | QEW | Substantially Equivalent | Inari Medical | 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 |
Compare with other makers
- All makers of Peripheral Mechanical Thrombectomy With Aspiration
- All makers of Catheter, Continuous Flush
Updated July 21, 2023. 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.