FDA product code DQG: Microsphere, Trace
DQG is the FDA product code for microsphere, trace. It is a Class III device, regulated under 21 CFR 870.1360 and reviewed by the Cardiovascular panel. Devices under DQG reach the market by PMA; FDA lists no cleared 510(k)s for it.
Definition
Call for PMAs 12/26/96 (61 FR 50706 (9/27/96))
Classification
| Field | Value |
|---|---|
| Device name | Microsphere, Trace |
| Device class | Class III |
| Regulation | 21 CFR 870.1360 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | PMA |
| Implant | Yes |
Recalls for DQG devices
openFDA lists no recalls for product code DQG.
Frequently asked questions
What is FDA product code DQG?
DQG is the FDA product code for microsphere, trace. It is a Class III device, regulated under 21 CFR 870.1360 and reviewed by the Cardiovascular panel.
What device class is DQG?
Class III, regulation 21 CFR 870.1360. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code DQG
- Run a recall and safety report across every DQG manufacturer
- Watch product code DQG 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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