FLOW-DIRECTED PEDIATRIC THERMODIL- CATH

FLOW-DIRECTED PEDIATRIC THERMODIL- CATH is an FDA 510(k)-cleared medical device (K843410) manufactured by Andover Medical, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 19, 1984. Regulation: 8.