510(k) K082905

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

K082905 is an FDA 510(k) premarket notification submitted by Medrad, Inc. for the device "MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T CARDIAC". The FDA issued a decision of Substantially Equivalent on January 12, 2009. 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.