FDA product code PJQ: Agent, Occluding, Vascular, Permanent
PJQ is the FDA product code for agent, occluding, vascular, permanent. It is a Class III device, reviewed by the Cardiovascular panel. Devices under PJQ reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code. FDA has posted 2 recalls for PJQ devices.
Definition
The device is a polymerizing agent intended for permanent occlusion of peripheral blood vessels.
Classification
| Field | Value |
|---|---|
| Device name | Agent, Occluding, Vascular, Permanent |
| Device class | Class III |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for PJQ devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 1 still open. Most recent: 2021-03-23.
| Year | Recalls |
|---|---|
| 2021 | 1 |
Frequently asked questions
What is FDA product code PJQ?
PJQ is the FDA product code for agent, occluding, vascular, permanent. It is a Class III device, reviewed by the Cardiovascular panel.
What device class is PJQ?
Class III. Typical premarket route: PMA.
Have PJQ devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2021-03-23.
Next steps
- Run an FDA pathway report with predicate devices for product code PJQ
- Run a recall and safety report across every PJQ manufacturer
- Watch product code PJQ 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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