510(k) K040636

CADD ADMINISTRATION SET WITH FLOW STOP, MEDICATION CASSETTE RESERVOIR WITH FLOW STOP AND EXTENSION SET by Smiths Medical MD, Inc. — Product Code FPA

K040636 is an FDA 510(k) premarket notification submitted by Smiths Medical MD, Inc. for the device "CADD ADMINISTRATION SET WITH FLOW STOP, MEDICATION CASSETTE RESERVOIR WITH FLOW STOP AND EXTENSION SET". The FDA issued a decision of Substantially Equivalent on May 19, 2004. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Smiths Medical MD, Inc. has at least 10 other 510(k) clearances on record.