Cardiomems, Inc. - FDA 510(k) Cleared Devices
Recent clearances: CARDIOMEMS ENDOSURE S2 14F WIRELESS AAA PRESSURE MEASUREMENT SYSTEM, MODEL# S2-2080, CARDIOMEMS ENDOSURE WIRELESS AAA PRESSURE MEASUREMENT SYSTEM, MODEL ADS-1001, CARDIOMEMS ENDOSURE PRESSURE SENSOR WITH DELIVERY SYSTEM, MODEL ADS-1001 AND INTERROGATOR, MODEL EMS 5001
5
Total
4
Cleared
1
Denied
FDA 510(k) Regulatory Record - Cardiomems, Inc. Cardiovascular ✕
5 devices
Cleared
Aug 19, 2008
CARDIOMEMS ENDOSURE S2 PRESSURE SENSOR WITH DELIVERY SYSTEM, MODEL S2-2080
Cardiovascular
15d
Cleared
Apr 05, 2007
CARDIOMEMS ENDOSURE S2 14F WIRELESS AAA PRESSURE MEASUREMENT SYSTEM, MODEL#...
Cardiovascular
24d
Cleared
Mar 15, 2007
CARDIOMEMS ENDOSURE WIRELESS AAA PRESSURE MEASUREMENT SYSTEM, MODEL ADS-1001
Cardiovascular
28d
Cleared
Oct 12, 2006
CARDIOMEMS ENDOSURE PRESSURE SENSOR WITH DELIVERY SYSTEM, MODEL ADS-1001 AND...
Cardiovascular
181d
Not Cleared
Oct 28, 2005
CARDIOMEMS ENDOSENSOR WITH DELIVERY SYSTEM AND ENDOSENSOR ELECTRONICS SYSTEM
Cardiovascular
80d