Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mivi Neuroscience, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
140 daysmedian FDA review time
357 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K222948 | Q Distal Access Catheter | Mivi Neuroscience, Inc. | 2023-09-19 | 357 | 0 |
| K212402 | MIVI Q Distal Access Catheter | Mivi Neuroscience, Inc. | 2021-12-16 | 136 | 0 |
| K163233 | MIVI 6F 25cm Mi-EXT Extension Catheter, MIVI 5F 25cm Mi-EXT | Mivi Neuroscience, Inc. | 2017-04-06 | 140 | 0 |
| K151396 | MIVI Mi-AXUS Guide Catheter | Mivi Neuroscience, Inc. | 2015-12-09 | 197 | 0 |
| K151825 | Viradius Neurowire | Mivi Neuroscience, Inc. | 2015-11-16 | 133 | 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