510(k) K873597

TUBING, POLYETHYLENE by Coeur Laboratories, Inc. — Product Code DXT

K873597 is an FDA 510(k) premarket notification submitted by Coeur Laboratories, Inc. for the device "TUBING, POLYETHYLENE". The FDA issued a decision of Substantially Equivalent on November 12, 1987. 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.