510(k) K843412

FLOW DIRECTED THERMODILUTION CATH W/VEN by Andover Medical, Inc. — Product Code KRB

K843412 is an FDA 510(k) premarket notification submitted by Andover Medical, Inc. for the device "FLOW DIRECTED THERMODILUTION CATH W/VEN". The FDA issued a decision of Substantially Equivalent on November 20, 1984. The device falls under product code KRB (Probe, Thermodilution), a Class II device regulated under 21 CFR 870.1915. Andover Medical, Inc. has at least 10 other 510(k) clearances on record.