Sensor, Pressure, Aneurysm, Implantable
Cardiovascular · 21 CFR 870.2855
This device is intended to measure the pressure in the aneurysm sac during and after an endovascular procedure.
Recent MDR events
33 adverse event reports on file
- ENDOSURE S2 PRESSURE MEASUREMENT SYSTEMJun 8, 2009MalfunctionCardiomems, Inc.3004936110-2009-00002
- ENDOSURE S2 PRESSURE MEASUREMENT SYSTEMApr 22, 2009OtherCardiomems, Inc.3004936110-2009-00001
- CARDIOMEMS ENDOSURE DELIVERY SYSTEMDec 17, 2008MalfunctionCardiomems, Inc.3004936110-2008-00008
- CARDIOMEMS ENDOSURE DELIVERY SYSTEMDec 3, 2008MalfunctionCardiomems, Inc.3004936110-2007-00013
- CARDIOMEMS ENDOSURE SENSORSep 19, 2008Cardiomems, Inc.3004936110-2008-00007
- CARDIOMEMS ENDOSURE SENSORSep 19, 2008MalfunctionCardiomems, Inc.3004936110-2008-00006
- CARDIOMEMS ENDOSURE DELIVERY SYSTEMMay 10, 2008MalfunctionCardiomems, Inc.3004936110-2008-00002
- CARDIOMEMS ENDOSURE DELIVERY SYSTEMMar 17, 2008MalfunctionCardiomems, Inc.3004936110-2008-00001
- ENDOSURE WIRELESS AAA PRESSURE MANAGMENT SYSTEMJan 28, 2008MalfunctionCardiomems, Inc.1003917
- CARDIOMEMS ENDOSURE DELIVERY SYSTEMJan 2, 2008InjuryCardiomems, Inc.3004936110-2007-00018
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
0 firms currently registered for this product code
No registered firms found for this product code.
510(k) clearances
5 clearances for this product code
- Cardiomems, Inc.Aug 19, 2008
K082191 · CARDIOMEMS ENDOSURE S2 PRESSURE SENSOR WITH DELIVERY SYSTEM, MODEL S2-2080
- Cardiomems, Inc.Apr 5, 2007
K070680 · CARDIOMEMS ENDOSURE S2 14F WIRELESS AAA PRESSURE MEASUREMENT SYSTEM, MODEL# S2-2080
- Cardiomems, Inc.Mar 15, 2007
K070448 · CARDIOMEMS ENDOSURE WIRELESS AAA PRESSURE MEASUREMENT SYSTEM, MODEL ADS-1001
- Cardiomems, Inc.Oct 12, 2006
K061046 · CARDIOMEMS ENDOSURE PRESSURE SENSOR WITH DELIVERY SYSTEM, MODEL ADS-1001 AND INTERROGATOR, MODEL EMS 5001
- Cardiomems, Inc.Oct 28, 2005
DEN050006 · CARDIOMEMS ENDOSENSOR WITH DELIVERY SYSTEM AND ENDOSENSOR ELECTRONICS SYSTEM