510(k) K911415

TRUMPET VALVE by B. Braun of America, Inc. — Product Code FMG

K911415 is an FDA 510(k) premarket notification submitted by B. Braun of America, Inc. for the device "TRUMPET VALVE". The FDA issued a decision of Substantially Equivalent on June 3, 1991. The device falls under product code FMG (Stopcock, I.V. Set), 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.