510(k) K101958

AMSINO I.V. ADMINISTRATION AND EXTENSION SETS by Amsino International, Inc. — Product Code FPA

K101958 is an FDA 510(k) premarket notification submitted by Amsino International, Inc. for the device "AMSINO I.V. ADMINISTRATION AND EXTENSION SETS". The FDA issued a decision of Substantially Equivalent on September 29, 2010. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Amsino International, Inc. has at least 10 other 510(k) clearances on record.