510(k) K861434

MODIFIED HC-417 BAG TO BAG & HC-418 BOTTLE TO BAG by Churchill Corp. — Product Code LHI

K861434 is an FDA 510(k) premarket notification submitted by Churchill Corp. for the device "MODIFIED HC-417 BAG TO BAG & HC-418 BOTTLE TO BAG". The FDA issued a decision of Substantially Equivalent on May 1, 1986. The device falls under product code LHI (Set, I.V. Fluid Transfer), a Class II device regulated under 21 CFR 880.5440. Churchill Corp. has at least 10 other 510(k) clearances on record.