510(k) K951802

SCIMED ENCORE ADVANTAGE KIT AND THE ESSENTIALS KIT by Scimed Life Systems, Inc. — Product Code DXT

K951802 is an FDA 510(k) premarket notification submitted by Scimed Life Systems, Inc. for the device "SCIMED ENCORE ADVANTAGE KIT AND THE ESSENTIALS KIT". The FDA issued a decision of Substantially Equivalent on Jul 21, 1995. The device falls under product code DXT (Injector And Syringe, Angiographic), a Class II device regulated under 21 CFR 870.1650. Scimed Life Systems, Inc. has 108 other 510(k) clearances on record.