510(k) K131204

ADVANCE CS CORONARY SINUS INFUSION CATHETER by Cook, Inc. — Product Code DQY

K131204 is an FDA 510(k) premarket notification submitted by Cook, Inc. for the device "ADVANCE CS CORONARY SINUS INFUSION CATHETER". The FDA issued a decision of Substantially Equivalent on January 29, 2014. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Cook, Inc. has at least 10 other 510(k) clearances on record.