510(k) K040385

MULTIPORT MANIFOLD SET WITH SWABABLE VALVES, MODEL 9900 by Quest Medical, Inc. — Product Code FPA

K040385 is an FDA 510(k) premarket notification submitted by Quest Medical, Inc. for the device "MULTIPORT MANIFOLD SET WITH SWABABLE VALVES, MODEL 9900". The FDA issued a decision of Substantially Equivalent on April 7, 2004. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Quest Medical, Inc. has at least 10 other 510(k) clearances on record.