NQH — Sensor, Pressure, Aneurysm, Implantable Class II
FDA product code NQH covers "Sensor, Pressure, Aneurysm, Implantable", a Class II medical device regulated under 21 CFR 870.2855. Submissions are reviewed by the Cardiovascular panel. Devices under this code are implants. At least 5 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NQH
- Device Class
- Class II
- Regulation Number
- 870.2855
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- Yes
Definition
This device is intended to measure the pressure in the aneurysm sac during and after an endovascular procedure.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K082191 | cardiomems | CARDIOMEMS ENDOSURE S2 PRESSURE SENSOR WITH DELIVERY SYSTEM, MODEL S2-2080 | August 19, 2008 |
| K070680 | cardiomems | CARDIOMEMS ENDOSURE S2 14F WIRELESS AAA PRESSURE MEASUREMENT SYSTEM, MODEL# S2-2 | April 5, 2007 |
| K070448 | cardiomems | CARDIOMEMS ENDOSURE WIRELESS AAA PRESSURE MEASUREMENT SYSTEM, MODEL ADS-1001 | March 15, 2007 |
| K061046 | cardiomems | CARDIOMEMS ENDOSURE PRESSURE SENSOR WITH DELIVERY SYSTEM, MODEL ADS-1001 AND INT | October 12, 2006 |
| DEN050006 | cardiomems | CARDIOMEMS ENDOSENSOR WITH DELIVERY SYSTEM AND ENDOSENSOR ELECTRONICS SYSTEM | October 28, 2005 |