510(k) K853072

CORON PRES MONITOR KIT MODEL 80 LEFT KIT MODEL 90 by Camino Laboratories, Inc. — Product Code DYB

K853072 is an FDA 510(k) premarket notification submitted by Camino Laboratories, Inc. for the device "CORON PRES MONITOR KIT MODEL 80 LEFT KIT MODEL 90". The FDA issued a decision of Substantially Equivalent on December 9, 1985. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Camino Laboratories, Inc. has at least 10 other 510(k) clearances on record.