510(k) K823920

COEURLOCK STERILE DISPOS. ANGIOGRAPHIC by Coeur Laboratories, Inc. — Product Code DXT

K823920 is an FDA 510(k) premarket notification submitted by Coeur Laboratories, Inc. for the device "COEURLOCK STERILE DISPOS. ANGIOGRAPHIC". The FDA issued a decision of Substantially Equivalent on February 18, 1983. The device falls under product code DXT (Injector And Syringe, Angiographic), a Class II device regulated under 21 CFR 870.1650. Coeur Laboratories, Inc. has at least 9 other 510(k) clearances on record.