FDA product code NQH: Sensor, Pressure, Aneurysm, Implantable
NQH is the FDA product code for sensor, pressure, aneurysm, implantable. It is a Class II device, regulated under 21 CFR 870.2855 and reviewed by the Cardiovascular panel. FDA has cleared 4 510(k) submissions under NQH. The average 510(k) review took 62 days (median 26). 1 De Novo request was granted under it.
Definition
This device is intended to measure the pressure in the aneurysm sac during and after an endovascular procedure.
Classification
| Field | Value |
|---|---|
| Device name | Sensor, Pressure, Aneurysm, Implantable |
| Device class | Class II |
| Regulation | 21 CFR 870.2855 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every NQH clearance
Top NQH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cardiomems, Inc. | 4 | 2008-08-19 |
Most recent NQH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K082191 | Cardiomems, Inc. | CARDIOMEMS ENDOSURE S2 PRESSURE SENSOR WITH DELIVERY SYSTEM, MODEL S2-2080 | 2008-08-19 | 15 |
| K070680 | Cardiomems, Inc. | CARDIOMEMS ENDOSURE S2 14F WIRELESS AAA PRESSURE MEASUREMENT SYSTEM, MODEL# S2-2080 | 2007-04-05 | 24 |
| K070448 | Cardiomems, Inc. | CARDIOMEMS ENDOSURE WIRELESS AAA PRESSURE MEASUREMENT SYSTEM, MODEL ADS-1001 | 2007-03-15 | 28 |
| K061046 | Cardiomems, Inc. | CARDIOMEMS ENDOSURE PRESSURE SENSOR WITH DELIVERY SYSTEM, MODEL ADS-1001 AND INTERROGATOR, MODEL EMS 5001 | 2006-10-12 | 181 |
Recalls for NQH devices
openFDA lists no recalls for product code NQH.
Frequently asked questions
What is FDA product code NQH?
NQH is the FDA product code for sensor, pressure, aneurysm, implantable. It is a Class II device, regulated under 21 CFR 870.2855 and reviewed by the Cardiovascular panel.
What device class is NQH?
Class II, regulation 21 CFR 870.2855. Typical premarket route: 510(k).
How long does a 510(k) take for product code NQH?
Across 4 cleared submissions the average was 62 days from receipt to decision (median 26).
Which companies have the most NQH clearances?
Cardiomems, Inc. (4).
Next steps
- Run an FDA pathway report with predicate devices for product code NQH
- Run a recall and safety report across every NQH manufacturer
- Watch product code NQH for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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