# K190063: Servator C SALF Solution

- Pathway: 510(k) (Traditional)
- Applicant: S.A.L.F. Spa
- Decided: Aug 14, 2019 after 211 days
- Product code: MSB (System And Accessories, Isolated Heart, Transport And Preservation)
- Device class: 2
- Regulation: 21 CFR 876.5880
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K883782 (1989). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991594: Celsior Cold Flush, Storage and Transport Solution for Hearts, Sangstat Medical Corp. (1999) Summary page 4.

## Indications for use
Servator C SALF Solution is intended for flushing and cold storage of hearts at the time of their removal from the donor in preparation for storage, transportation, and eventual transplantation into a recipient.

Source page: https://510kreport.com/device/K190063
Methodology: https://510kreport.com/methodology