Mivi Neuroscience Inc
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 5
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2441-2021 | Class II | MIVI Super 90 Guide Catheters, MIVI Mi-Axus 8F Catheters, REF MIA-9080S (80 cm length); MIA-9090S (9 | July 23, 2021 |
| Z-2442-2021 | Class II | MIVI Super 90 8F Guide Catheter, 95 cm, REF MIA-9095S-IDE, For Investigational Use Only; sterile, an | July 23, 2021 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K222948 | Q Distal Access Catheter | September 19, 2023 |
| K212402 | MIVI Q Distal Access Catheter | December 16, 2021 |
| K163233 | MIVI 6F 25cm Mi-EXT Extension Catheter, MIVI 5F 25cm Mi-EXT Extension Catheter, MIVI 4F 30cm Mi-EXT | April 6, 2017 |
| K151396 | MIVI Mi-AXUS Guide Catheter | December 9, 2015 |
| K151825 | Viradius Neurowire | November 16, 2015 |