NQH
5 FDA 510(k) clearances · Product code
28 daysmedian time to decision
181 days90th percentile
5clearances measured
FDA profile
- Official device name
- Sensor, Pressure, Aneurysm, Implantable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2855
- Medical specialty
- Cardiovascular
- Flags
- Implant
- FDA definition
- This device is intended to measure the pressure in the aneurysm sac during and after an endovascular procedure.
- Adverse events (MAUDE)
- 2006: 5 · 2007: 17 · 2008: 8
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| CARDIOMEMS ENDOSURE S2 PRESSURE SENSOR WITH DELIVERY SYSTEM, MODEL S2-2080 (K082191) | Cardiomems, Inc. | 2008-08-19 |
| CARDIOMEMS ENDOSURE S2 14F WIRELESS AAA PRESSURE MEASUREMENT SYSTEM, MODEL# S2-2080 (K070680) | Cardiomems, Inc. | 2007-04-05 |
| CARDIOMEMS ENDOSURE WIRELESS AAA PRESSURE MEASUREMENT SYSTEM, MODEL ADS-1001 (K070448) | Cardiomems, Inc. | 2007-03-15 |
| CARDIOMEMS ENDOSURE PRESSURE SENSOR WITH DELIVERY SYSTEM, MODEL ADS-1001 AND INTERROGATOR, MODEL EMS 5001 (K061046) | Cardiomems, Inc. | 2006-10-12 |
| CARDIOMEMS ENDOSENSOR WITH DELIVERY SYSTEM AND ENDOSENSOR ELECTRONICS SYSTEM (DEN050006) | Cardiomems, Inc. | 2005-10-28 |
Track NQH automatically
Every clearance here is in the API, with alerts when new ones post.