FDA 510(k) Applications for Medical Device Product Code "NQH"
(Sensor, Pressure, Aneurysm, Implantable)

FDA 510(k) Number Applicant Device Name Decision Date
DEN050006 CARDIOMEMS INC CARDIOMEMS ENDOSENSOR WITH DELIVERY SYSTEM AND ENDOSENSOR ELECTRONICS SYSTEM 10/28/2005
K082191 CARDIOMEMS INC CARDIOMEMS ENDOSURE S2 PRESSURE SENSOR WITH DELIVERY SYSTEM, MODEL S2-2080 08/19/2008
K070448 CARDIOMEMS INC CARDIOMEMS ENDOSURE WIRELESS AAA PRESSURE MEASUREMENT SYSTEM, MODEL ADS-1001 03/15/2007
K061046 CARDIOMEMS, INC. CARDIOMEMS ENDOSURE PRESSURE SENSOR WITH DELIVERY SYSTEM, MODEL ADS-1001 AND INTERROGATOR, MODEL EMS 5001 10/12/2006
K070680 CARDIOMEMS, INC. CARDIOMEMS ENDOSURE S2 14F WIRELESS AAA PRESSURE MEASUREMENT SYSTEM, MODEL# S2-2080 04/05/2007


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