510(k) K153729

8F FlowGate2 Balloon Guide Catheter by Concentric Medical — Product Code DQY

K153729 is an FDA 510(k) premarket notification submitted by Concentric Medical for the device "8F FlowGate2 Balloon Guide Catheter". The FDA issued a decision of Substantially Equivalent on January 27, 2016. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Concentric Medical has at least 10 other 510(k) clearances on record.