510(k) K921594

HAEMOTROL MODEL #HT-SB/6 BURETTE SET by Haemotronic, Inc. — Product Code FPA

K921594 is an FDA 510(k) premarket notification submitted by Haemotronic, Inc. for the device "HAEMOTROL MODEL #HT-SB/6 BURETTE SET". The FDA issued a decision of Substantially Equivalent on December 24, 1992. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Haemotronic, Inc. has at least 5 other 510(k) clearances on record.