FDA applicant
Concentric Medical, Inc.
FDA records 46 decisions for Concentric Medical, Inc. (Mountain View, CA) from 2001 to 2018: 45 510(k) clearances and 1 De Novo grant. Most are in product codes DQY (Catheter, Percutaneous) and NRY (Catheter, Thrombus Retriever). Its devices cite 50 predicates, 45 of them its own earlier devices. 21 recalls are linked to its devices.
FDA’s records also spell it “Concentric Medical”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Concentric Medical, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2018
2026 so far, outlined.
Recalls per year
6in 2024
Class I Class II/III not classified
Planning a device like Concentric Medical, Inc.’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