Eden Prairie, MN, US · 2 510(k) clearances · 2 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| QJP | — | — | — | 2 | 2023-09-19 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2021-07-23 | Class II | Terminated | Z-2442-2021 | MIVI Super 90 8F Guide Catheter, 95 cm, REF MIA-9095S-IDE, For Investigational Use Only; sterile, and Super 90 8F Guide … | — | There is potential for nonsterility of product due to a possible defect in the pouch seal. |
| 2021-07-23 | Class II | Terminated | Z-2441-2021 | MIVI Super 90 Guide Catheters, MIVI Mi-Axus 8F Catheters, REF MIA-9080S (80 cm length); MIA-9090S (90 cm length), and MI… | — | There is potential for nonsterility of product due to a possible defect in the pouch seal. |