FDA product code NDQ: System, Catheter Or Guidewire, Steerable (Magnetic)
NDQ is the FDA product code for system, catheter or guidewire, steerable (magnetic). It is a Class II device, regulated under 21 CFR 870.1290 and reviewed by the Neurology panel. FDA has cleared 2 510(k) submissions under NDQ. The average 510(k) review took 196 days (median 196).
Classification
| Field | Value |
|---|---|
| Device name | System, Catheter Or Guidewire, Steerable (Magnetic) |
| Device class | Class II |
| Regulation | 21 CFR 870.1290 |
| Review panel | NE — Neurology |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every NDQ clearance
Top NDQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Stereotaxis, Inc. | 2 | 2006-10-19 |
Most recent NDQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K060967 | Stereotaxis, Inc. | NIOBE MAGNETIC NAVIGATION SYSTEM W/NAVIGANT WORKSTATION | 2006-10-19 | 195 |
| K051373 | Stereotaxis, Inc. | CRONUS GUIDEWIRE, MODEL 001-001470-1 | 2005-12-09 | 197 |
Recalls for NDQ devices
openFDA lists no recalls for product code NDQ.
Frequently asked questions
What is FDA product code NDQ?
NDQ is the FDA product code for system, catheter or guidewire, steerable (magnetic). It is a Class II device, regulated under 21 CFR 870.1290 and reviewed by the Neurology panel.
What device class is NDQ?
Class II, regulation 21 CFR 870.1290. Typical premarket route: 510(k).
How long does a 510(k) take for product code NDQ?
Across 2 cleared submissions the average was 196 days from receipt to decision (median 196).
Which companies have the most NDQ clearances?
Stereotaxis, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code NDQ
- Run a recall and safety report across every NDQ manufacturer
- Watch product code NDQ 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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