Mirandola (Modena), IT · 17 510(k) clearances · 5 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | Class II | Cardiovascular | 4 | 2026-01-30 |
| DTZ | Oxygenator, Cardiopulmonary Bypass | Class II | Cardiovascular | 4 | 2023-11-16 |
| DTN | Reservoir, Blood, Cardiopulmonary Bypass | Class II | Cardiovascular | 2 | 2025-12-22 |
| DTM | Filter, Blood, Cardiopulmonary Bypass, Arterial Line | Class II | Cardiovascular | 2 | 2024-12-20 |
| CAC | Apparatus, Autotransfusion | Class II | Anesthesiology | 2 | 2024-08-16 |
| DRE | Dilator, Vessel, For Percutaneous Catheterization | Class II | Cardiovascular | 1 | 2025-12-19 |
| DTR | — | — | — | 1 | 2025-05-30 |
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | Class II | Gastroenterology, Urology | 1 | 2025-04-25 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2020-07-29 | Class II | Terminated | Z-2988-2020 | Perceval Dual Collapser, Size S/M, REF: ICV1235, Sterile EO, Rx Only, CE, UDI: 08022057014832 - Product Usage: he Dual… | — | LivaNova received complaints indicating the impossibility to collapse Perceval valve during procedure. The Dual Collapser is a component of the Perceval single … |
| 2020-07-29 | Class II | Terminated | Z-2987-2020 | Perceval Single Use Accessory Kit, Size M, REF: ICV1350, Sterile EO, Rx Only, CE, UDI: 8022057015259 - Product Usage: h… | — | LivaNova received complaints indicating the impossibility to collapse Perceval valve during procedure. The Dual Collapser is a component of the Perceval single … |
| 2020-07-29 | Class II | Terminated | Z-2986-2020 | Perceval Single Use Accessory Kit, Size S, REF: ICV1349, Sterile EO, Rx Only, CE, UDI: 8022057015211 - Product Usage: he… | — | LivaNova received complaints indicating the impossibility to collapse Perceval valve during procedure. The Dual Collapser is a component of the Perceval single … |
| 2020-07-29 | Class II | Terminated | Z-2985-2020 | Perceval Single Use Accessory Kit, Size M, REF: ICV1346, Sterile EO, Rx Only, CE, UDI: 8022057015228 - Product Usage: he… | — | LivaNova received complaints indicating the impossibility to collapse Perceval valve during procedure. The Dual Collapser is a component of the Perceval single … |
| 2020-07-29 | Class II | Terminated | Z-2984-2020 | Perceval Single Use Accessory Kit, Size S, REF: ICV1345, Sterile EO, Rx Only, CE, UDI: 8022057015204 - Product Usage: … | — | LivaNova received complaints indicating the impossibility to collapse Perceval valve during procedure. The Dual Collapser is a component of the Perceval single … |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-01-30 | K253671 | Dual Stage Venous Cannulae | DWF | Class II | Cardiovascular |
| 2025-12-22 | K251783 | Inspire HCR and HCR DUAL cardiotomy reservoirs | DTN | Class II | Cardiovascular |
| 2025-12-19 | K253616 | ProtekDilate Vascular Access Kit | DRE | Class II | Cardiovascular |
| 2025-06-27 | K250610 | Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310) | DWF | Class II | Cardiovascular |
| 2025-05-30 | K250150 | VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set with shunt); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood Cardioplegia Set Mini) | DTR | — | — |
| 2025-04-25 | K243264 | DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14) | KDI | Class II | Gastroenterology, Urology |
| 2024-12-20 | K242953 | KIDS Arterial Filters | DTM | Class II | Cardiovascular |
| 2024-11-18 | K242092 | MICRO Arterial Filters | DTM | Class II | Cardiovascular |
| 2024-08-16 | K241236 | XTRA Collection sets; XTRA Sequestration set X | CAC | Class II | Anesthesiology |
| 2024-04-29 | K240584 | XTRA Autotransfusion System (with XTRA Bowl sets) | CAC | Class II | Anesthesiology |
| 2024-02-22 | K240193 | R501 - R502 aortic root cannulae with and without vent line (R501-15: R501-20: R501-26. R502-15; R502-20: R502-26) | DWF | Class II | Cardiovascular |
| 2023-11-16 | K231652 | D100 KIDS; D101 KIDS | DTZ | Class II | Cardiovascular |
| 2023-06-10 | K223361 | BMR 1900 PHISIO | DTN | Class II | Cardiovascular |
| 2021-07-12 | K211495 | EOS PMP | DTZ | Class II | Cardiovascular |
| 2020-11-17 | K200612 | R501 aortic root cannula without vent line, R502 aortic root cannula with vent line | DWF | Class II | Cardiovascular |
| 2020-08-13 | K201916 | Inspire 6M Hollow Fiber oxygenator, Inspire 7M Hollow Fiber oxygenator, Inspire 8M Hollow Fiber oxygenator | DTZ | Class II | Cardiovascular |
| 2020-06-12 | K200683 | INSPIRE 7FM Hollow fiber oxygenator with integrated arterial filter, INSPIRE 7F Hollow fiber oxygenator with integrated arterial filter and hardshell reservoir, INSPIRE 7F DUAL Hollow fiber oxygenator with integrated arterial filter and hardshell reservoir | DTZ | Class II | Cardiovascular |