510(k) K192375

Intellifuse Administration and Intellifuse Blood Administration Sets by Smiths Medical Asd, Inc. — Product Code FPA

K192375 is an FDA 510(k) premarket notification submitted by Smiths Medical Asd, Inc. for the device "Intellifuse Administration and Intellifuse Blood Administration Sets". The FDA issued a decision of Substantially Equivalent on September 18, 2020. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Smiths Medical Asd, Inc. has at least 10 other 510(k) clearances on record.