510(k) K061046

CARDIOMEMS ENDOSURE PRESSURE SENSOR WITH DELIVERY SYSTEM, MODEL ADS-1001 AND INTERROGATOR, MODEL EMS 5001 by Cardiomems, Inc. — Product Code NQH

K061046 is an FDA 510(k) premarket notification submitted by Cardiomems, Inc. for the device "CARDIOMEMS ENDOSURE PRESSURE SENSOR WITH DELIVERY SYSTEM, MODEL ADS-1001 AND INTERROGATOR, MODEL EMS 5001". The FDA issued a decision of Substantially Equivalent on October 12, 2006. 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.