Toronto, CA · 1 510(k) clearances · 1 recalls (1 Class I)
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| OBJ | Catheter, Ultrasound, Intravascular | Class II | Cardiovascular | 1 | 2026-04-17 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2025-03-12 | Class I | Ongoing | Z-1585-2025 | Brand Name: Novasight Hybrid System Product Name: Novasight Hybrid Catheter Model/Catalog Number: TA-06-0001 Product … | — | Due to manufacturing issues there is a potential for the catheter sheath to detach. |