510(k) K023937

COOK VASCULAR SERPENTA CORONARY SINUS INTRODUCER SYSTEM by Cook Vascular, Inc. — Product Code DYB

K023937 is an FDA 510(k) premarket notification submitted by Cook Vascular, Inc. for the device "COOK VASCULAR SERPENTA CORONARY SINUS INTRODUCER SYSTEM". The FDA issued a decision of Substantially Equivalent on May 27, 2003. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Cook Vascular, Inc. has at least 10 other 510(k) clearances on record.