510(k) K070680

CARDIOMEMS ENDOSURE S2 14F WIRELESS AAA PRESSURE MEASUREMENT SYSTEM, MODEL# S2-2080 by Cardiomems, Inc. — Product Code NQH

K070680 is an FDA 510(k) premarket notification submitted by Cardiomems, Inc. for the device "CARDIOMEMS ENDOSURE S2 14F WIRELESS AAA PRESSURE MEASUREMENT SYSTEM, MODEL# S2-2080". The FDA issued a decision of Substantially Equivalent on April 5, 2007. The device falls under product code NQH (Sensor, Pressure, Aneurysm, Implantable), a Class II device regulated under 21 CFR 870.2855. Cardiomems, Inc. has at least 4 other 510(k) clearances on record.