Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ev3 Neurovascular · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K093681 | MERIDIAN GUIDEWIRE | Ev3 Neurovascular | 2010-01-26 | 60 | 0 |
| K091458 | HYPERGLIDE OCCLUSION BALLOON SYSTEM, HYPERFORM OCCLUSION BAL | Ev3 Neurovascular | 2009-10-15 | 150 | 0 |
| K092495 | HYPERGLIDE OCCLUSION BALLOON SYSTEM, MODEL 104-4310, 104-431 | Ev3 Neurovascular | 2009-09-22 | 39 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda