510(k) K092298

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

K092298 is an FDA 510(k) premarket notification submitted by Concentric Medical, Inc. for the device "MODIFICATION TO MODIFIED HD GUIDE CATHETER". The FDA issued a decision of Substantially Equivalent on November 5, 2009. 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.