510(k) K921597

CAVH/CVVH/CAVHD SET MODEL #HT-HF/505 by Haemotronic, Inc. — Product Code FJK

K921597 is an FDA 510(k) premarket notification submitted by Haemotronic, Inc. for the device "CAVH/CVVH/CAVHD SET MODEL #HT-HF/505". The FDA issued a decision of Substantially Equivalent on February 24, 1995. The device falls under product code FJK (Set, Tubing, Blood, With And Without Anti-Regurgitation Valve), a Class II device regulated under 21 CFR 876.5820. Haemotronic, Inc. has at least 5 other 510(k) clearances on record.