510(k) K141285

BUSSE EXTENSION SET by Busse Hospital Disposables — Product Code FPA

K141285 is an FDA 510(k) premarket notification submitted by Busse Hospital Disposables for the device "BUSSE EXTENSION SET". The FDA issued a decision of Substantially Equivalent on February 19, 2015. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Busse Hospital Disposables has at least 10 other 510(k) clearances on record.