510(k) K213778

IV Administration Set by B.Braun Medical, Inc. — Product Code FPA

K213778 is an FDA 510(k) premarket notification submitted by B.Braun Medical, Inc. for the device "IV Administration Set". The FDA issued a decision of Substantially Equivalent on March 3, 2022. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. B.Braun Medical, Inc. has at least 10 other 510(k) clearances on record.