Product code NQH

Device name: Sensor, Pressure, Aneurysm, Implantable
Medical specialty: Cardiovascular
Device class: 2
Regulation number: 870.2855
Review panel: CV
Implant: Y
Life sustaining/supporting: N
GMP exempt: N
Third party review: N
Summary malfunction reporting: Eligible
Definition: This device is intended to measure the pressure in the aneurysm sac during and after an endovascular procedure.
Source: FDA openFDA device classification dataset

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

Related 510(k) Records#