510(k) K162272

Fluent inflation device by Vascular Solutions, Inc. — Product Code MAV

K162272 is an FDA 510(k) premarket notification submitted by Vascular Solutions, Inc. for the device "Fluent inflation device". The FDA issued a decision of Substantially Equivalent on October 20, 2016. The device falls under product code MAV (Syringe, Balloon Inflation), a Class II device regulated under 21 CFR 870.1650. Vascular Solutions, Inc. has at least 10 other 510(k) clearances on record.