510(k) K072886

MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T by Medrad, Inc. — Product Code DXT

K072886 is an FDA 510(k) premarket notification submitted by Medrad, Inc. for the device "MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T". The FDA issued a decision of Substantially Equivalent on December 21, 2007. The device falls under product code DXT (Injector And Syringe, Angiographic), a Class II device regulated under 21 CFR 870.1650. Medrad, Inc. has at least 10 other 510(k) clearances on record.