510(k) K002689

SWABSITE SWABBABLE VALVE, MODEL 245000 by Quest Medical, Inc. — Product Code FPA

K002689 is an FDA 510(k) premarket notification submitted by Quest Medical, Inc. for the device "SWABSITE SWABBABLE VALVE, MODEL 245000". The FDA issued a decision of Substantially Equivalent on March 6, 2001. 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.