510(k) K890292

PCA-10, 10CC DISP. ANGIOGRAPHY CONTROL SYRINGE by Coeur Laboratories, Inc. — Product Code DXT

K890292 is an FDA 510(k) premarket notification submitted by Coeur Laboratories, Inc. for the device "PCA-10, 10CC DISP. ANGIOGRAPHY CONTROL SYRINGE". The FDA issued a decision of Substantially Equivalent on June 22, 1989. 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.