SangStat Medical files for 510(k) for Celsior:
This article was originally published in Clinica
Executive Summary
SangStat Medical has filed a 510(k) with the US FDA for its Celsior organ preserving solution. Data support the use of the solution for flushing and cold storage of human hearts at the time of removal from the donor in preparation for storage and eventual transplantation, says SangStat.