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)
FDA 510(k) clearance K250150 · decided 2025-05-30
Clearance details
- K-number
- K250150
- Device name
- 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)
- Applicant
- Sorin Group Italia S.R.L.
- Decision
- Substantially Equivalent
- Date received
- 2025-01-21
- Decision date
- 2025-05-30
- Days to decision
- 129 days
- Clearance type
- Special
- Product code
- DTR
- Device class
- 2
- Regulation number
- 870.4240
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mirandola (Modena), IT
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
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| Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM) (K240908) | Spectrum Medical , Ltd. | 2025-07-08 |
| MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System Uncoated (K240190) | Medtronic | 2024-02-23 |
| Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M) (K223879) | Quara S.R.L. | 2023-04-13 |
| Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat Exchanger (K220110) | Qura S.R.L | 2022-05-06 |
| Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exchanger (K212688) | Qura S.R.L | 2022-01-10 |
| MPS 3 ND Myocardial Protection System (K201984) | Quest Medical, Inc. | 2020-11-20 |
| MPS 3 Myocardial Protection System (K200438) | Quest Medical, Inc. | 2020-06-19 |
| MPS2 Myocardial Protection System Console (K173716) | Quest Medical, Inc. | 2018-10-01 |
| MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface (Bridge System) (K162774) | Medtronic, Inc. | 2017-02-10 |
| MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface; MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface with Bridge; MYOtherm XP Cardioplegia Delivery System; MYOtherm XP Cardioplegia Delivery System with Bridge (K162958) | Medtronic, Inc. | 2017-02-01 |
| PLEGIOX CARDIOPLEGIA HEAT EXCHANGER WITH SOFTLINE COATING, MODEL BIO-CHX 30 (K090555) | Maquet Cardiopulmonary, AG | 2009-12-23 |
Recalls involving this device
No recalls on record reference this clearance.