Mivi Neuroscience, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Mivi Neuroscience, Inc.” (first 2015, latest 2023), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 140 days. Since 2017 the median was 140 days, against 115 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2015 | 2 | 165 |
| 2016 | 0 | — |
| 2017 | 1 | 140 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 136 |
| 2022 | 0 | — |
| 2023 | 1 | 357 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Mivi Neuroscience, Inc. took a median 140 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 115 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DQY | Catheter, Percutaneous | 2 | 2 |
| QJP | Catheter, Percutaneous, Neurovasculature | 2 | 2 |
| MOF | Guide, Wire, Catheter, Neurovasculature | 1 | 1 |
Review panels
- Neurology (3)
- Cardiovascular (2)
Most recent Mivi Neuroscience, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K222948 | Q Distal Access Catheter | QJP | 2023-09-19 | 357 |
| K212402 | MIVI Q Distal Access Catheter | QJP | 2021-12-16 | 136 |
| K163233 | MIVI 6F 25cm Mi-EXT Extension Catheter, MIVI 5F 25cm Mi-EXT Extension Catheter, MIVI 4F 30cm Mi-EXT Extension Catheter, MIVI 3F 43cm Mi-EXT Extension Catheter | DQY | 2017-04-06 | 140 |
| K151396 | MIVI Mi-AXUS Guide Catheter | DQY | 2015-12-09 | 197 |
| K151825 | Viradius Neurowire | MOF | 2015-11-16 | 133 |
Recalls
2 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2021-07-23.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Mivi Neuroscience, Inc. is the lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT04437862: A Study to Evaluate the Q Revascularization System for Neurointervention in Acute Ischemic Stroke (Completed, started 2020-10-27)
- NCT04089917: A Study of the Use of the Q Aspiration Catheter to Remove Clot in Stroke Patients (Completed, started 2019-09-16)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Mivi Neurovascular, Inc. (2 510(k)s)
- Mivi, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Mivi Neuroscience, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Mivi Neuroscience, Inc.” (first 2015, latest 2023), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Mivi Neuroscience, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Mivi Neuroscience, Inc. is 140 days. Since 2017: 140 days, versus 115 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Mivi Neuroscience, Inc.?
The most frequent FDA product codes under this applicant name are DQY (Catheter, Percutaneous, 2); QJP (Catheter, Percutaneous, Neurovasculature, 2); MOF (Guide, Wire, Catheter, Neurovasculature, 1).
Next steps
- See all 5 Mivi Neuroscience, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DQY, Mivi Neuroscience, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.