510(k) K143412

ADROIT Guiding Catheter by Cordis Corporation — Product Code DQY

K143412 is an FDA 510(k) premarket notification submitted by Cordis Corporation for the device "ADROIT Guiding Catheter". The FDA issued a decision of Substantially Equivalent on January 14, 2015. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Cordis Corporation has at least 10 other 510(k) clearances on record.