510(k) K110483

MODIFIED HD GUIDE CATHETER by Concentric Medical, Inc. — Product Code DQY

K110483 is an FDA 510(k) premarket notification submitted by Concentric Medical, Inc. for the device "MODIFIED HD GUIDE CATHETER". The FDA issued a decision of Substantially Equivalent on April 4, 2011. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Concentric Medical, Inc. has at least 10 other 510(k) clearances on record.