Sorin Group Italia S.R.L.
FDA 510(k) & PMA Approved Devices — 24 products
Total Devices24
Categories10
Latest FDA decision2026-01-30
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K253671 | Dual Stage Venous Cannulae | DWF | 2026-01-30 | View |
| 510(k) | K251783 | Inspire HCR and HCR DUAL cardiotomy reservoirs | DTN | 2025-12-22 | View |
| 510(k) | K253616 | ProtekDilate Vascular Access Kit | DRE | 2025-12-19 | View |
| 510(k) | K250610 | Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310) | DWF | 2025-06-27 | View |
| 510(k) | 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 | 2025-05-30 | View |
| 510(k) | K243264 | DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14) | KDI | 2025-04-25 | View |
| 510(k) | K242953 | KIDS Arterial Filters | DTM | 2024-12-20 | View |
| 510(k) | K242092 | MICRO Arterial Filters | DTM | 2024-11-18 | View |
| 510(k) | K241236 | XTRA Collection sets; XTRA Sequestration set X | CAC | 2024-08-16 | View |
| 510(k) | K240584 | XTRA Autotransfusion System (with XTRA Bowl sets) | CAC | 2024-04-29 | View |
| 510(k) | K240193 | R501 - R502 aortic root cannulae with and without vent line (R501-15: R501-20: R501-26. R502-15; R502-20: R502-26) | DWF | 2024-02-22 | View |
| 510(k) | K231652 | D100 KIDS; D101 KIDS | DTZ | 2023-11-16 | View |
| 510(k) | K223361 | BMR 1900 PHISIO | DTN | 2023-06-10 | View |
| 510(k) | K211495 | EOS PMP | DTZ | 2021-07-12 | View |
| 510(k) | K200612 | R501 aortic root cannula without vent line, R502 aortic root cannula with vent line | DWF | 2020-11-17 | View |
| 510(k) | K201916 | Inspire 6M Hollow Fiber oxygenator, Inspire 7M Hollow Fiber oxygenator, Inspire 8M Hollow Fiber oxygenator | DTZ | 2020-08-13 | View |
| 510(k) | 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 | 2020-06-12 | View |
| 510(k) | K190650 | Revolution Centrifugal Blood Pump | KFM | 2019-08-07 | View |
| 510(k) | K190690 | INSPIRE 7 Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy Reservoir, INSPIRE 7M Hollow Fiber Oxygenator, INSPIRE 7 Dual Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy Reservoir | DTZ | 2019-04-13 | View |
| 510(k) | K180979 | PureFlex Arterial Cannulae | DWF | 2018-11-16 | View |
No matching devices.
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