510(k) K020892

ACIST GENTOO CONTRAST INJECTION SYSTEM by Acist Medical Systems — Product Code DXT

K020892 is an FDA 510(k) premarket notification submitted by Acist Medical Systems for the device "ACIST GENTOO CONTRAST INJECTION SYSTEM". The FDA issued a decision of Substantially Equivalent on January 27, 2003. The device falls under product code DXT (Injector And Syringe, Angiographic), a Class II device regulated under 21 CFR 870.1650. Acist Medical Systems has at least 10 other 510(k) clearances on record.