510(k) K260261

Gravity Blood Sets with 200µm Filter by B.Braun Medical, Inc. — Product Code FPA

K260261 is an FDA 510(k) premarket notification submitted by B.Braun Medical, Inc. for the device "Gravity Blood Sets with 200µm Filter". The FDA issued a decision of Substantially Equivalent on Oct 22, 2026. 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 150 other 510(k) clearances on record.