Sensor, Pressure, Aneurysm, Implantable
FDA product code NQH · Class II (moderate risk) · 21 CFR 870.2855 · Cardiovascular
This device is intended to measure the pressure in the aneurysm sac during and after an endovascular procedure.
4510(k) clearances
0PMA approvals
0recalls
Implantimplanted device
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K082191 | Cardiomems Endosure S2 Pressure Sensor with Delivery System, Model S2-2080NQH · Abbreviated | Cardiomems, Inc. | 08/19/2008SE |
| K070680 | Cardiomems Endosure S2 14F Wireless Aaa Pressure Measurement System, Model# S2-2080NQH · Special | Cardiomems, Inc. | 04/05/2007SE |
| K070448 | Cardiomems Endosure Wireless Aaa Pressure Measurement System, Model ADS-1001NQH · Abbreviated | Cardiomems, Inc. | 03/15/2007SE |
| K061046 | Cardiomems Endosure Pressure Sensor with Delivery System, Model ADS-1001 and…NQH · Traditional | Cardiomems, Inc. | 10/12/2006SE |