510(k) K943181

DISPENSING PIN WITH ONE-WAY VALVE by B. Braun of America, Inc. — Product Code LHI

K943181 is an FDA 510(k) premarket notification submitted by B. Braun of America, Inc. for the device "DISPENSING PIN WITH ONE-WAY VALVE". The FDA issued a decision of Substantially Equivalent on September 29, 1994. The device falls under product code LHI (Set, I.V. Fluid Transfer), a Class II device regulated under 21 CFR 880.5440. B. Braun of America, Inc. has at least 10 other 510(k) clearances on record.