510(k) K945298

SMARTFLOW I ADMINISTRATION SET by River Medical, Inc. — Product Code FPA

K945298 is an FDA 510(k) premarket notification submitted by River Medical, Inc. for the device "SMARTFLOW I ADMINISTRATION SET". The FDA issued a decision of Substantially Equivalent on June 14, 1995. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. River Medical, Inc. has at least 10 other 510(k) clearances on record.