FDA applicant
Ev3, Inc.
FDA records 40 decisions for Ev3, Inc. (Plymouth, MN) from 2003 to 2014: 40 510(k) clearances. Most are in product codes FGE (Stents, Drains And Dilators For The Biliary…) and LIT (Catheter, Angioplasty, Peripheral, Transluminal). Its devices cite 73 predicates, 27 of them its own earlier devices. 67 recalls are linked to its devices.
FDA’s records also spell it “Ev3 Corporation”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Ev3, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2014
2026 so far, outlined.
Recalls per year
1in 2024
Class I Class II/III not classified
Planning a device like Ev3, 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