Data / Medical devices / Ireland / Neuravi Limited
Neuravi Limited: FDA-registered device maker in Galway Galway(County), Ireland, 6 510(k) clearances
Neuravi Limited is registered with the FDA (registration 3011370111) in Galway Galway(County), Ireland. It lists 2 device types. The FDA files 6 510(k) clearances under its listings, the newest dated September 25, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011370111
- Address
- Block 3 Ballybrit Business Park, Galway Galway(County), Ireland, H91K5YD
- Owner or operator
- Neuravi Limited (10057686)
- Roles
- Specification developer
- First device listed
- May 14, 2018
- Registered through
- 2026
- Brand names listed
- CATHETER, THROMBUS RETRIEVER, Catheter, Percutaneous, Neurovasculature, EMBOTRAP III
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Percutaneous, Neurovasculature | QJP | 2 | Specification developer | accessdata.fda.gov |
| Catheter, Thrombus Retriever | NRY | 2 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| September 25, 2025 | K251789 | EMBOTRAP III Revascularization Device | NRY | Substantially Equivalent | Neuravi Limited | accessdata.fda.gov |
| April 18, 2024 | K233924 | EMBOGUARD Balloon Guide Catheter | QJP | Substantially Equivalent | Neuravi Limited | accessdata.fda.gov |
| December 17, 2021 | K212340 | EMBOGUARD Balloon Guide Catheter | QJP | Substantially Equivalent | Neuravi Limited | accessdata.fda.gov |
| July 30, 2021 | K211338 | EMBOTRAP III Revascularization Device | NRY | Substantially Equivalent | Neuravi, Ltd. | accessdata.fda.gov |
| July 14, 2020 | K193063 | EMBOTRAP III Revascularization Device | NRY | Substantially Equivalent | Neuravi, Ltd. | accessdata.fda.gov |
| May 9, 2018 | K173452 | EmboTrap ll Revascularization Device | NRY | Substantially Equivalent | Neuravi, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated September 25, 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.