FDA applicant
Neuravi, Ltd.
FDA records 7 decisions for Neuravi, Ltd. (Galway, IE) from 2018 to 2025: 7 510(k) clearances. Most are in product codes NRY (Catheter, Thrombus Retriever) and QJP (Catheter, Percutaneous, Neurovasculature). Since 2016 its 510(k)s took a median of 127 days from receipt to decision, against 129 for FDA’s reviews in the same codes and years. Its devices cite 12 predicates, 8 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Neuravi Limited”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Neuravi, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2018.
Planning a device like Neuravi, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report