Servator C SALF Solution
by S.A.L.F. Spa EUDAMED510(k)
Active
510(k) K190063
Overview
The Servator C SALF Solution is a sterile, non-pyrogenic extracellular perfusion and preservation solution designed for hypothermic storage and transport of isolated thoracic and abdominal organs, including the heart, lung, kidney, liver, and pancreas. Classified as a system and accessories device for isolated heart transport and preservation, it maintains organ viability under controlled hypothermic conditions (2°C to 8°C).
This solution is supplied as a sterile, single-use formulation intended for clinical use in transplantation settings. It is regulated under FDA 510(k) clearance (K190063) and MDR compliance, with no third-party involvement. Storage and handling must adhere to sterile protocols, and its use is restricted to medical specialties in gastroenterology and urology as per advisory committee classifications. The device is classified as Class II under FDA regulations.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK190063 | Date14 Aug 2019 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- MSB
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5880
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
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Questions
What types of organs can the Servator C SALF Solution be used to preserve and transport, and how does it maintain their viability?
The Servator C SALF Solution is designed for hypothermic storage and transport of isolated thoracic and abdominal organs, including the heart, lung, kidney, liver, and pancreas. Its formulation maintains organ viability by providing a sterile, non-pyrogenic extracellular environment under controlled hypothermic conditions (2°C to 8°C), ensuring optimal preservation during transport.
Is the Servator C SALF Solution intended for single-use or can it be reused? How should it be stored?
The Servator C SALF Solution is explicitly supplied as a sterile, single-use formulation, meaning each unit is intended for one clinical application only. Storage must adhere to strict sterile protocols to preserve its integrity, as it is not designed for reuse.
What medical specialties are authorized to use the Servator C SALF Solution, and how is its regulatory status defined?
The Servator C SALF Solution is authorized for use in the specialties of gastroenterology and urology, as classified by the advisory committee (GU). Regulatory clearance was granted under the FDA’s 510(k) pathway (K190063) and complies with MDR requirements, with no third-party involvement in its submission.
How is the Servator C SALF Solution classified under FDA regulations, and what does this mean for its use?
The Servator C SALF Solution is classified as a Class II medical device under FDA regulations, indicating it poses moderate risk and requires special controls to ensure safety and effectiveness. This classification applies to its use as a system and accessories device for isolated heart transport and preservation, ensuring compliance with stricter manufacturing and labeling standards.
What temperature range is recommended for preserving organs using the Servator C SALF Solution, and why is this important?
The solution maintains organ viability within a controlled hypothermic range of 2°C to 8°C, which is critical for slowing cellular metabolism and reducing damage during transport. Deviating from this range could compromise organ integrity and increase the risk of complications during transplantation.