510(k) K933294

MIS CLEAN-SET FLUSHING UNIT AND ACCESSORIES by Aesculap, Inc. — Product Code FPB

K933294 is an FDA 510(k) premarket notification submitted by Aesculap, Inc. for the device "MIS CLEAN-SET FLUSHING UNIT AND ACCESSORIES". The FDA issued a decision of Substantially Equivalent on Feb 9, 1994. The device falls under product code FPB (Filter, Infusion Line), a Class II device regulated under 21 CFR 880.5440. Aesculap, Inc. has at least 10 other 510(k) clearances on record.