510(k) K971712

COEUR 130 ML ANGIOGRAPHIC SYRINGE by Coeur Laboratories, Inc. — Product Code DXT

K971712 is an FDA 510(k) premarket notification submitted by Coeur Laboratories, Inc. for the device "COEUR 130 ML ANGIOGRAPHIC SYRINGE". The FDA issued a decision of Substantially Equivalent on October 8, 1997. 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.