510(k) K991594

CELSIOR COLD FLUSH, STORAGE AND TRANSPORT SOLUTION FOR HEARTS by Sangstat Medical Corp. — Product Code MSB

K991594 is an FDA 510(k) premarket notification submitted by Sangstat Medical Corp. for the device "CELSIOR COLD FLUSH, STORAGE AND TRANSPORT SOLUTION FOR HEARTS". The FDA issued a decision of Substantially Equivalent on August 5, 1999. The device falls under product code MSB (System And Accessories, Isolated Heart, Transport And Preservation), a Class II device regulated under 21 CFR 876.5880. Sangstat Medical Corp. has at least 2 other 510(k) clearances on record.